Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations.

Essential Functions:

Risk-Based Quality Management (RBQM) Leadership
•    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance.
•    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors.
•    Integrate RBQM principles into study planning, execution, oversight, and close-out activities.
•    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy.

Central Risk Identification, Monitoring & Mitigation

•    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks.
•    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials.
•    Oversee centralized risk monitoring and trending to enable early detection of critical risks.
•    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons 

Learned & Risk Library Management (Core Ownership)

•    Establish and maintain a centralized Clinical Risk Library, capturing:
o    Known and emerging risks
o    Root causes
o    Mitigation strategies
o    Effectiveness of controls
•    Lead lessons learned activities across trials, audits, inspections, and CAPAs.
•    Ensure lessons learned are:
o    Systematically captured
o    Analyzed for trends
o    Fed back into RBQM planning, SOPs, training, and future studies
•    Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness.

Quality Oversight & Regulatory Compliance

•    Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs.
•    Provide centralized quality oversight across trials, CROs, and vendors.
•    Support audit and inspection readiness activities, including:
o    Risk-based inspection preparation
o    Impact assessments
o    CAPA development and effectiveness checks

Vendor & CRO Risk Oversight

•    Design and implement risk-based oversight strategies for CROs and external vendors.
•    Monitor vendor performance using quality metrics and risk indicators.
•    Lead or support quality governance discussions with external partners.
•    Ensure vendor-related risks are integrated into the central risk library and lessons learned framework.

Data-Driven Quality & Continuous Improvement

•    Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making.
•    Generate enterprise-level risk trend reports and insights for senior leadership.
•    Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned.
•    Champion a culture of proactive quality and continuous improvement across Clinical Operations.

Cross-Functional Collaboration & RBQM Expertise

•    Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance.
•    Provide RBQM training and coaching to study teams and cross-functional stakeholders.
•    Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics.
•    Participate as an observing member on assigned study teams to provide real-time quality and risk support.

SOP Management & Governance Support

•    Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates.
•    Support governance activities, senior management reporting, and quality metrics standardization.
•    Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support.

Requirements:

Education
•    Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required)
•    Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred)

Experience
•    10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM
•    Demonstrated experience leading enterprise or cross-study risk management frameworks
•    Strong background in audit/inspection readiness, CAPA management, and vendor oversight
•    Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements

Technical Skills
•    Expertise with RBQM tools, centralized monitoring systems, and risk analytics
•    Experience defining and using KRIs, QTLs, and quality metrics
•    Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI)
•    Exposure to AI or predictive analytics for quality monitoring (preferred)

Working Conditions:

Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines.

The anticipated salary for this position will be $175,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary of Job:

 

As the Manufacturing Site IT Infrastructure Lead, you will own and manage the planning, implementation, and execution of IT infrastructure at Kyowa Kirin's new manufacturing facility. You will play a key role in standing up a state-of-the-art biologics manufacturing site by ensuring the IT infrastructure, manufacturing networks, and mobile strategy support site objectives while aligning with regional and global standards.

This position is responsible for the IT infrastructure supporting both manufacturing operations and office environments. The role requires extensive infrastructure expertise, from strategic planning and implementation through ongoing technical support and lifecycle management within a Life Sciences manufacturing environment.

As a leader, you will foster a collaborative, inclusive, and people-focused culture while driving team development, stakeholder alignment, and measurable business results. You will help guide the organization through change in a rapidly evolving biotech environment while maintaining a patient-focused mindset.

 

Essential Functions

 

IT Infrastructure & Technical Leadership

• Lead network operations, server administration, security, and end-user support across manufacturing, laboratory, and office environments.
• Design, implement, and maintain secure, scalable, and highly available network infrastructure supporting real-time manufacturing operations.
• Support on-premises and cloud server infrastructure, including implementation, maintenance, and lifecycle management.
• Manage firewalls and ensure secure segregation of manufacturing, laboratory, and office networks.
• Support IT infrastructure for manufacturing automation platforms including Process Control Systems (PCS), Manufacturing Execution Systems (MES), Data Historians, and Building Management Systems (BMS).
• Monitor infrastructure performance, proactively identify issues, and minimize system downtime.
• Develop and execute site-specific IT infrastructure strategies aligned with regional and global enterprise standards.
• Ensure compliance with GMP, EHS, corporate procedures, cybersecurity requirements, and applicable regulatory standards.
• Stay current on emerging technologies and best practices within pharmaceutical manufacturing and IT infrastructure.
• Develop site IT strategy aligned with global manufacturing IT and digital roadmap initiatives.
• Manage relationships with IT vendors and support contract negotiations.
• Provide technical support and troubleshooting for end users.
• Translate business needs into technical solutions to support project execution.
• Maintain IT infrastructure and computer systems inventories.
• Support lifecycle management programs to ensure infrastructure hardware remains current and supported.

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Leadership Responsibilities

• Establish clear goals, drive accountability, and deliver measurable business results.
• Foster open communication, provide constructive feedback, and effectively manage conflict.
• Mentor, coach, and develop team members while supporting continuous learning.
• Promote diversity, inclusion, and a respectful team culture.
• Build a supportive work environment that recognizes achievements and encourages work-life balance.
• Lead collaboratively while modeling organizational values and integrity.
• Demonstrate emotional intelligence and sound decision-making under pressure.
• Guide teams through organizational change with clear communication and adaptability.
• Apply situational leadership by adjusting leadership style to meet team needs.
• Build alignment across stakeholders and facilitate decisions that support organizational objectives.

 

Education

 

• Bachelor's degree in Information Technology, Computer Science, or a related discipline preferred.

Experience

 

• Minimum of seven years of overall IT experience.
• At least three years supporting manufacturing environments.
• Experience serving as an IT Infrastructure technical lead within pharmaceutical or manufacturing organizations.
• Strong experience with network architecture, firewall design, network segmentation, and infrastructure maintenance.
• Broad technical knowledge across networking, cybersecurity, infrastructure, and manufacturing systems.
• Experience with network security protocols and best practices.
• Experience supporting virtual server environments and cloud infrastructure.
• Experience using network monitoring and troubleshooting tools.
• Hands-on experience with backup, restore, archival, and disaster recovery methodologies.
• Knowledge of cybersecurity standards, data protection, and regulatory compliance.
• Strong understanding of Good Manufacturing Practice (GMP) regulations and their impact on IT systems.
• Experience supporting international organizations within global environments.
• Experience supporting startup biopharmaceutical manufacturing facilities is preferred.

Technical Skills

 

• Microsoft Office Suite
• Linux operating systems
• TCP/IP networking fundamentals
• DNS and DHCP
• ServiceNow or other IT Service Management (ITSM) platforms
• Microsoft Azure
• Amazon Web Services (AWS)
• Cisco Firewalls
• Cisco Switches

Non-Technical Skills

 

• Results-oriented with strong accountability and follow-through.
• Comfortable working in fast-paced, evolving environments with changing priorities.
• Strong organizational skills and attention to detail.
• Excellent communication and relationship-building abilities.
• Active listener with strong interpersonal skills.
• Growth mindset and commitment to continuous learning.
• Collaborative and inclusive leadership style.
• High integrity and professionalism.
• Innovative, resourceful, and proactive problem solver.
• Enterprise mindset with the ability to work across functions and organizations.

 

 

Physical Demands

• Initially work within an active construction environment before transitioning into a fully operational biotech manufacturing facility in Sanford, North Carolina.
• Position requires 100% onsite presence and is not eligible for remote or hybrid work.

---

Working Conditions

• Up to 10% domestic travel.
• Limited international travel as business needs require.

 

Compensation & Benefits

The anticipated annual salary for this position is $156,900 to $215,700. The actual salary offered at the commencement of employment may vary based on several factors, including, but not limited to, relevant experience, skill set, qualifications, education (including applicable licenses and certifications), job-related knowledge, geographic location, and other business and organizational needs.

The listed salary range is just one component of the overall compensation package. At Kyowa Kirin North America, we provide a comprehensive range of benefits, including:

• 401(k) with Company Match
• Annual Bonus Program (Sales Bonus for Sales Positions)
• Generous PTO and Holiday Schedule, including Summer and Winter Shut-Downs
• Sick Days
• Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drug, and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long-Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

---

Equal Employment Opportunity

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions.

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified individuals without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affectional preference, citizenship status, or any other characteristic protected by applicable law.

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Applicant Privacy Notice

When you apply for a position through this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), located at 510 Carnegie Center Drive, Princeton, NJ 08540 USA. The Controller can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com.

The Controller's Data Protection Officer can be contacted at usprivacyoffice@kyowakirin.com.

Your personal data will be processed for the purposes of managing the Controller's recruitment-related activities, including setting up and conducting interviews and assessments, evaluating applicants, and supporting recruitment and hiring activities. Such processing is legally permissible under Article 6(1)(f) of the General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the legitimate interests pursued by the Controller, including the solicitation, evaluation, and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States and engaged by the Controller to manage its recruitment and hiring process. Accordingly, if you are located outside the United States, your personal data will be transferred to the United States once submitted through this site. The transfer will be made using appropriate safeguards, including standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by the Controller for as long as necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, request correction or deletion of your personal data, request restriction of processing, exercise your right to data portability, and lodge a complaint with an appropriate EU supervisory authority.

If you have questions regarding the use of your personal data, please contact usprivacyoffice@kyowakirin.com.

---

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless the agency has been engaged directly by Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location. Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

 

#LI-TT1

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

Kyowa Kirin Information & Communication Technology is seeking to add a dynamic and independent Regulatory and PV IT technology professional to its R&D IT Healthcare team. This self-starting leader will partner with IT leadership, business partners and stakeholders globally, to deliver increasing capabilities to Regulatory and PV.  This person will oversee business relationship management, operational excellence, vendor management and project execution.  They will work with teams to innovate and manage business demand, prioritize initiatives, and ensure value realization.

Essential Functions:

•    Partner with business teams to support operational, tactical, and strategic outcomes
•    Work with business stakeholders in defining, designing, proposing, and implementation oversight of solutions
•    Support and ensure the successful completion of analytical, building, testing and deployment tasks of the projects and initiatives within the Clinical Business organizations
•    Partner with global IT colleagues on RA and PV initiatives
•    Ensure operational excellence in day-to-day operations of clinical and associated suites and platforms
•    Work on global teams as RA and PV technology SME
•    Capture, manage, and prioritize business demand and manage investment portfolios
•    Manage area and project budgets, vendors, contracts

Requirements:

Education
•    Bachelor's degree in science, Engineering, or Business field required. 
•    Advanced Degree in Technical, Engineering field preferred

Experience
•    A strong computer science background, demonstrated through industry experience
•    At least 10 years’ experience in pharmaceutical R&D technology support
•    Knowledge of business processes in RA and PV 
•    Demonstrated operational support background
•    GxP and SDLC fluency
•    A track record of partnering cross-functionally with a wide range of stakeholders and cross-functional teams 
•    A passion for communication with partners and delivering technology outcomes that drive business goals

Technical Skills
•    Proficient in MS Office Suite. 
•    Experience with Veeva RIMS, Oracle Argus.

Non-Technical Skills
•    Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. 
•    Strong interpersonal and communication skills. 
•    Strong work ethic is required. Detail oriented and excellent follow through. 
•    Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. 
•    Cultural sensitivity and ability to develop consensus within a multinational organization.

The anticipated salary for this position will be $175,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Director Technology Development Research provides strategic, scientific, and technical leadership for technology research supporting cell and gene therapy programs, with a primary focus on allogeneic immune cell platforms. The role leads a research group responsible for advancing core capabilities in iPSC biology, immune cell differentiation, cellular engineering, genome editing, and related platform technologies.  The position sets scientific direction across multiple projects and platform initiatives, ensures alignment of research execution with portfolio priorities, and develops decision-ready data packages to support downstream development, external collaboration, and future technology transfer. The role also manages and develops scientific leaders and staff, drives cross-functional collaboration, and represents Technology Research in internal governance and scientific forums.

*This position is targeted at the Director level; however, candidates with exceptional experience, expertise, and demonstrated leadership capabilities may be considered for appointment at the Senior Director level.

Essential Functions:

•    Lead the Technology Development Research group responsible for allogeneic immune cell therapy research, cell and gene therapy technology development, platform capability expansion, and genome editing capabilities. 
•    Define scientific strategy for technology projects and platform initiatives, including goals, milestones, decision criteria, risks, and resource needs aligned with portfolio priorities. 
•    Oversee execution of research plans led by project leaders, and scientists, ensuring timely delivery of high-quality data and recommendations for project and portfolio decisions. 
•    Provide senior-level technical leadership in iPSC biology, immune cell differentiation, cellular engineering, genome editing, viral and non-viral delivery, and molecular biology. 
•    Translate early-stage research outputs into development-ready data packages, including CMC-relevant elements such as process characterization, analytical strategy, potency and functional assays, comparability, and documentation. 
•    Propose, prioritize, and lead  technology initiatives and enhancements to strengthen the cell therapy portfolio. 
•    Manage, mentor, and develop project leaders, scientists, and research staff, fostering scientific rigor, accountability, leadership capability, and cross-functional collaboration. 
•    Oversee resource planning, personnel prioritization, external partner engagement, and budget input for assigned projects and technology initiatives. 
•    Represent Technology Research in governance discussions, project reviews, scientific forums, and selected external engagements; communicate complex scientific and strategic topics clearly to senior stakeholders. 
•    Prepare, review, and endorse project documentation. 
•    Ensure research activities are conducted with high scientific quality, documentation discipline, safety awareness, and compliance with internal policies, external standards, and regulatory expectations. 
•    Perform other duties as assigned. 

Requirements:

Education
Ph.D. in Biological Sciences, Immunology, Molecular Biology, Biochemistry, or closely related discipline required. 

Experience
•    10+ years in biopharmaceutical industry, with significant experience in cell therapy research and strong expertise in stem cell biology and iPSC-derived immune cell platforms. 
•    Hands-on experience with human iPSC culture, immune cell differentiation, phenotypic and functional characterization, and cell engineering approaches, including genome editing and viral and/or non-viral delivery methods. 
•    Demonstrated experience translating early-stage research and process development into CMC-relevant deliverables, including process characterization, analytical strategy, documentation, and technology transfer support. 
•    Experience advancing cell and gene therapy programs toward IND submission, including integration of scientific, translational, CMC, regulatory, and external partner inputs into a coherent development strategy. 
•    Deep understanding of relevant regulatory guidelines and quality frameworks, including GMP, ISO, and ICH; direct experience engaging with FDA or other Health Authorities for cell therapy products is strongly preferred. 
•    Experience selecting, managing, and providing scientific oversight of CROs and CDMOs to ensure timely execution, delivery, and alignment with project objectives. 
•    Demonstrated ability to serve as the accountable scientific lead for assigned projects, providing strategic guidance and data-driven experimental decision-making. 
•    Experience leading development, qualification, or validation of potency assays and other QC release assays is desirable. 
•    CAR immune cell engineering experience is a strong plus. 

Technical Skills
•    Strong scientific expertise in stem cell biology, immunology, cancer biology, and cell therapy platform development. 
•    Deep technical understanding of iPSC culture, cell differentiation, cellular engineering, genome editing, viral and non-viral delivery, and molecular biology. 
•    Experience with immune cell characterization methods, including flow cytometry, immunostaining, functional assays, and related analytical approaches. 
•    Ability to interpret complex scientific, translational, and CMC-relevant data and translate findings into clear recommendations for project and portfolio decisions. 
•    Strong written and verbal communication skills, including ability to present complex scientific and strategic topics to senior stakeholders. 
•    Proficiency with Microsoft Office Suite. 

Non-Technical Skills
•    Demonstrated leadership, accountability, and follow-through in a dynamic, fast-paced research environment. 
•    Strong ability to organize, prioritize, meet deadlines, make decisions, and adapt quickly as priorities evolve. 
•    Scientific curiosity, innovation mindset, and commitment to continuous learning and development. 
•    Detail-oriented approach with strong documentation discipline and commitment to high-quality scientific execution. 
•    Ability to build consensus and collaborate effectively across functions, geographies, and working styles within a multinational organization. 
•    Strong interpersonal skills and ability to mentor, influence, and develop scientific talent.

Physical Demands:

Normal office environment with prolonged sitting and extensive computer work

Working Conditions:

Requires up to 15% domestic and international travel

The anticipated salary for a Director level hire will be $190,700 to $246,800 and if a *Sr. Director level hire is chosen the anticipated salary will be $225,200 to $291,500. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

 

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #La Jolla #San Diego #On-site

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Territory Coverage: Minnesota, Iowa, North Dakota, and South Dakota
Location Requirement: Candidate must reside within the territory.
Travel: Approximately 50%, including overnight travel.

 

The Oncology Account Manager is a critical role in establishing KKNA as a leader in Oncology and Rare Diseases by demonstrating our commitment to supporting healthcare providers in improving patient health outcomes and becoming a trusted resource throughout the patient journey.

The Oncology Account Manager will drive effective hospital system and account planning, management, and selling strategies across the assigned territory. The individual will identify key stakeholders within assigned hospital systems and accounts and build strong relationships with those individuals throughout the patient journey.

This includes understanding and educating referral networks to help identify appropriate patients, converting to Poteligeo where appropriate, and supporting maintenance on Poteligeo through appropriate multidisciplinary support across the patient care network.

The Oncology Account Manager will also serve as the lead point of contact for account management activities within assigned hospital networks, academic institutions, and surrounding practices, working closely with Market Access, Sales, Marketing, and Medical Affairs teams.

 

Essential Functions:

• Effective Hospital System and Account Planning, Management, and Selling
  • Drive effective account planning and management for target hospital systems by understanding the patient journey, identifying key influencers within each account, and building relationships to drive sales.
  • Develop and maintain a deep understanding of oncology and dermatology centers within the assigned region, including key stakeholders and patient flows.
  • Understand and apply knowledge of healthcare industry trends, market conditions, and the Market Access environment within Oncology and Dermatology, including pharmacy economics and the payer/reimbursement landscape.
  • Support Market Access needs when necessary.
  • Review and analyze product performance within accounts and evolve actions and strategies as appropriate.
• Understanding and Educating Referral Networks to Identify Appropriate Patients and Support Maintenance
  • Map patient flow and influence across institutions and community practices.
  • Educate referral and co-management networks on disease best practices.
  • Incorporate an understanding of patient flow across institutions and community practices into business planning and the daily execution of sales calls.
  • Identify and track potential patients for appropriate follow-up with HCPs.
  • Support maintenance on Poteligeo by helping facilitate appropriate multidisciplinary HCP support throughout the patient's care network.
• Converting to Poteligeo Where Appropriate
  • Demonstrate a strong understanding of current or pending clinical pathways within an institution.
  • Collaborate cross-functionally with internal and external customers to develop and implement actionable business plans that support required formulary and protocol/pathway additions and drive sales volume within an account.
  • Conduct formal and informal presentations and communicate complex scientific information fluently in a professional, compliant, ethical, and effective manner.
  • Support access to KKNA products across accounts by working with KOLs, providers, pharmacy, and P&T committees, where appropriate.
  • Demonstrate highly effective account management skills and exemplary selling competencies.
  • Maintain knowledge of Oncology and Rare Disease standards of care and emerging clinical trends, and articulate approved, on-label product information related to these topics.
• Compliance
  • Refer requests for off-label information to KKNA's Medical Department through the MIR process.
  • Strictly adhere to all relevant regulatory and compliance guidelines and company policies.

 

Job Requirements

Education

• Bachelor’s degree required.

Experience

• A minimum of 5 years of pharmaceutical sales experience with a minimum of 3 years of pharmaceutical account management experience.
• A minimum of 3 years’ experience within institutional, oncology, or rare disease sales.
• Proven track record of sales success.
• Must have a high degree of understanding of the Buy & Bill & Market Access marketplace.
• Must have a strong track record of therapeutic area/product knowledge.

Technical Skills

• Proficient in MS Office Suite and Veeva is a must.
• Excellent organizational/communication skills, initiative, and ambition to succeed are all essential.
• Valid US Driver’s License

Non-Technical Skills

Highly motivated and with great attention to detail. Strong endurance to work under tight timelines and complex/changing situations.  Excellent written and oral communication skills including the ability to present via PowerPoint in front of large groups. Excellent problem-solving skills. Broad level of interpersonal skills and flexibility.   Cultural sensitivity and ability to develop consensus within a multinational organization. 

Physical Demands:

• Normal office environment with prolonged sitting and extensive computer work. Extensive driving and potential air travel with overnights are expected in some territories. The ability to safely and successfully operate a motor vehicle is required
• This position will be field based and will require approx. 50% overnight travel depending on territory.

 

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

 

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

Annualized base salary ranges from $150,000 – $175,000 plus sales incentive; actual salaries will vary and may be above or below this range commensurate with various factors including but not limited to experience, education, training, and merit. 

This position is eligible for a company car through the Company’s FLEET program.

Kyowa Kirin provides a comprehensive compensation and benefits package which includes:

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, and Health Savings Account, Business Travel Insurance, Employee Assistance Programs
• Pet Insurance
• Retirement Savings 401k with company match and annual discretionary profit sharing
• Well-Being and Work-Life Programs Including Gympass, Nutrition Counseling, , Volunteer Time Off, Flexible Work Arrangements, Parental Leave, Adoption Assistance, and TouchCare Insurance & Billing Support
• Generous Paid Time Off, Sick Time, & Paid Holidays
• Perks and Discounts with Tickets at Work and LifeMart
• Reward & Recognition Programs
• Career Development and Training 

 

 

#LI-PE1

#LI-Field 

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario

Summary of Job

Territory: This position covers  Dallas, TX, Houston, TX, and Phoenix, AZ territories, along with surrounding markets throughout the region. Candidates must live within the Territory 

The Medical Science Liaison (MSL) is a field-based member of the Medical Affairs organization responsible for serving as the scientific and clinical expert for Kyowa Kirin's therapeutic areas and products. The MSL establishes and maintains trusted scientific relationships with healthcare professionals (HCPs), key opinion leaders (KOLs), researchers, and other external stakeholders to facilitate the exchange of accurate, balanced, and evidence-based scientific information.

The MSL supports Medical Affairs objectives by providing scientific and clinical expertise, generating actionable medical insights, supporting evidence generation, and contributing to medical strategy while ensuring all activities are conducted in compliance with applicable laws, regulations, industry standards, and company policies.

---

Essential Functions

• Establish, develop, and maintain strategic scientific relationships with national, regional, and local key opinion leaders (KOLs), healthcare professionals (HCPs), investigators, and other external stakeholders.
• Serve as a trusted scientific expert by engaging in compliant, peer-to-peer scientific exchange and providing accurate, balanced, and evidence-based medical and clinical information regarding Kyowa Kirin products, disease states, and emerging clinical data, including responses to unsolicited medical information requests.
• Gather, analyze, and communicate actionable medical insights, unmet medical needs, and competitive intelligence from field interactions to inform Medical Affairs strategy, evidence generation, and cross-functional decision-making.
• Function as the regional scientific expert by identifying external stakeholder needs and connecting them with appropriate Medical Affairs resources, initiatives, and scientific collaborations.
• Support the planning and execution of Medical Affairs objectives through scientific engagement at national, regional, and local medical congresses, advisory boards, investigator meetings, and other scientific forums.
• Establish and maintain collaborative relationships with clinical investigators and support investigator-initiated studies (IIS) and company-sponsored clinical research in partnership with Clinical Operations, in accordance with company policies and regulatory requirements.
• Develop and deliver scientific presentations, educational programs, and clinical resources for healthcare professionals and other appropriate stakeholders.
• Deliver scientific education and training to internal cross-functional partners on disease states, therapeutic landscapes, clinical data, and Kyowa Krin products.
• Build and maintain effective cross-functional partnerships across Medical Affairs, Clinical Development, Commercial, Market Access, Regulatory Affairs, and other internal functions while maintaining appropriate boundaries between scientific and commercial activities.
• Communicate important product safety information in accordance with Medical Affairs, Research & Development, pharmacovigilance, and applicable regulatory requirements.
• Maintain current scientific knowledge through continuous review of clinical literature, treatment guidelines, and emerging data within assigned therapeutic area(s).
• Disseminate product safety information to healthcare professionals in accordance with Medical Affairs, Research & Development, DHPL directives, regulatory requirements, and company policies.
• Participate in cross-functional projects, Medical Affairs initiatives, and strategic planning activities, serving as a scientific resource to internal stakeholders.
• Mentor and support the development of fellow MSLs by sharing scientific expertise, field insights, and best practices, as appropriate.
• Perform all responsibilities in compliance with applicable laws, regulations, industry codes, company policies, and the highest standards of scientific integrity and ethical conduct.

---

Education

• Advanced clinical or scientific degree or healthcare professional credential required (e.g., MD, DO, PhD, PharmD, NP, PA, MS, or equivalent). Doctoral degree (MD, DO, PhD, or PharmD) preferred

Experience

• Minimum of two (2) years of experience as a Medical Science Liaison (MSL), field-based medical professional, or in a related clinical, scientific, or Medical Affairs role preferred.
• Background in the Rare-Disease therapeutic area or related disease state preferred.
• Demonstrated ability to engage healthcare professionals (HCPs), key opinion leaders (KOLs), investigators, and other external stakeholders through compliant scientific exchange.
• Ability to interpret and communicate clinical and scientific data effectively to diverse audiences.
• Familiarity with clinical research activities, including investigator-initiated studies (IIS) and/or company-sponsored clinical trials, preferred.
• Involvement in scientific congresses, advisory boards, investigator meetings, or other medical education activities preferred.

Technical Skills

• Understanding of assigned disease states, therapeutic landscapes, treatment guidelines, and current standards of care.
• Familiarity with clinical research methodology, evidence generation strategies, and interpretation of clinical trial data.
• Working knowledge of FDA regulations, Good Clinical Practice (GCP), pharmacovigilance requirements, Office of Inspector General (OIG) guidance, and applicable industry standards.
• Proficiency in evaluating medical literature, synthesizing scientific information, and translating complex data into meaningful insights for healthcare professionals and internal stakeholders.
• Skilled in delivering scientifically accurate, balanced, and compliant presentations to external and internal audiences.
• Experience utilizing Medical Affairs systems, customer relationship management (CRM) platforms, and proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Demonstrated capability to analyze medical insights, identify trends, and support data-driven decision-making within Medical Affairs.
• Skilled in delivering scientifically accurate, balanced, and compliant presentations to external and internal audiences.
• Experience utilizing Medical Affairs systems, customer relationship management (CRM) platforms, and proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Demonstrated capability to analyze medical insights, identify trends, and support data-driven decision-making within Medical Affairs.
• Capacity to manage multiple priorities, organize field-based activities, and operate effectively in a dynamic, cross-functional environment.
• Outstanding interpersonal skills, including the ability to build strong working relationships and effectively manage conflict.

Non-Technical Skills

Ability to thrive in a fast-paced environment while managing ambiguity effectively. Commitment to the highest ethical, legal, regulatory, and scientific standards. Demonstrated professionalism, sound judgment, and scientific integrity. Passion for personal learning and professional development. Cultural sensitivity and adaptability within multinational organizations.

Physical Requirements

The role requires the ability to work in a field-based environment with frequent travel, including extended periods of sitting during air, ground, and other forms of transportation. The position may require prolonged use of computers and other office equipment, as well as the ability to attend and participate in scientific meetings, conferences, advisory boards, and healthcare professional engagements. The employee must be able to navigate various work environments and maintain effective communication and presentation capabilities while traveling and performing job responsibilities

Working Conditions

Field-based position requiring up to 70% travel by air and ground transportation, including overnight travel and occasional weekend commitments to support scientific congresses, advisory boards, and other Medical Affairs activities. Must reside within the assigned territory and maintain proximity to a major airport to support regional coverage requirements, which may encompass a broad geographic area requiring regular travel. A valid driver’s license and the ability to operate a motor vehicle as required for business travel are required.

The anticipated salary for this position will be  $170,000 – $195,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

 

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

 

 

#LI-PE1

#LI-FIELD

 

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Territory Coverage:
Alexandria, Charlottesville, Norfolk, Portsmouth, Richmond, and Virginia Beach, Virginia.

Summary of Job

The Regional Business Manager (RBM) plays a critical role in establishing Kyowa Kirin as a leader in Rare Disease by partnering with healthcare providers to improve patient outcomes and serving as a trusted resource throughout the patient journey.

The RBM is responsible for developing strategic relationships across assigned hospital systems, academic medical centers, and community practices to support appropriate identification, referral, and long-term treatment of patients with Crysvita. This role requires a strong understanding of referral pathways, multidisciplinary care models, and the Rare Disease landscape to help ensure eligible patients have access to appropriate therapy and remain on treatment.

The RBM serves as the primary commercial point of contact within the territory and collaborates closely with cross-functional partners, including Market Access, Medical Affairs, Marketing, Patient Services, and Sales, to deliver a coordinated customer experience and execute business objectives.

Essential Functions

• Maintain a high degree of clinical knowledge to engage effectively with Endocrinologists, Geneticists, Rheumatologists, and other appropriate healthcare professionals in the areas of X-Linked Hypophosphatemia (XLH) and Tumor-Induced Osteomalacia (TIO).
• Focus efforts on achieving the greatest positive impact for patients.
• Manage patient identification by understanding the patient journey to support timely diagnosis and enable appropriate access to therapy.
• Clearly understand and implement the marketing plan, accurately articulate the value proposition, and utilize only on-label and approved marketing materials to achieve sales and patient objectives on a monthly, quarterly, and annual basis.
• Communicate disease state, product, and formulary information in a truthful, balanced, and non-misleading manner, consistent with Kyowa Kirin's compliance policies and all applicable laws and regulations.
• Manage the assigned territory using sound judgment and discretion while executing the brand strategy to maximize performance within the assigned customer population. This includes physicians within specialty medical practices and their staff, specialists within hospitals and clinics, and other appropriate healthcare professionals throughout the territory.
• Analyze local and regional business and managed market trends to develop both short- and long-term territory goals that support a successful business plan.
• Work compliantly within a cross-functional matrix environment, including Patient Services, Specialty Infusion Pharmacies, and Managed Markets, while handling confidential patient information in accordance with Kyowa Kirin policies and applicable privacy requirements.
• Build productive partnerships with internal stakeholders to develop compliant selling strategies that align with company and territory business plans.
• Seek guidance from management and/or Compliance and Legal whenever there is uncertainty regarding whether a proposed activity may violate company policies or applicable laws.
• Utilize a consultative, solution-oriented selling approach to meet the needs of healthcare professionals treating patients with X-Linked Hypophosphatemia (XLH) and Tumor-Induced Osteomalacia (TIO).
• Manage territory marketing resources and promotional speaker program budgets in accordance with all Kyowa Kirin compliance policies.
• Share best practices and actively participate in regional and national meetings.
• Utilize the CRM system to accurately document account profiles and pre-call and post-call activities.

Compliant  

• Refers requests for off-label information to KKI’s medical department through the MIR process. 
• Strictly adhere to relevant regulatory and compliance guidelines and company policies. 

Job Requirements:

Education 

• Bachelor’s degree in Science or Business, MBA, Pharmacy/Medical Degree. 

Experience 

• Minimum of 5 years of specialty pharmaceutical sales experience.
• Demonstrated success in improving patient outcomes by enabling access to appropriate therapies.
• Ability to discuss therapeutic strategies to inform and influence healthcare decision-makers.
• Proven ability to develop and apply clinical and business expertise, along with effective selling skills.
• Strong verbal, presentation, influencing, and written communication skills.
• Must reside within or be willing to relocate to the assigned geography.
• Ability to adapt to changing business needs, priorities, and work responsibilities.
• Demonstrated commitment to continuous learning, professional development, and self-improvement.

Preferred Qualifications

• Experience executing marketing strategies at the local level.
• Demonstrated business and strategic planning skills with the ability to identify unique selling opportunities and adapt to changing market conditions.
• Demonstrated understanding of the managed care landscape and its impact on business.
• Strong collaboration skills with a proven ability to work effectively in cross-functional teams.
• Experience selling products that require extensive coordination with Patient Services.
• Working knowledge of the Rare Disease market.
• Demonstrated ability to analyze complex technical data and develop strategic, actionable business plans.

Travel Requirements

• Must possess a valid U.S. driver's license with a clean driving record.
• Ability to travel overnight within the assigned territory as business needs require.

Technical Skills

• Proficient in Microsoft Office Suite.

Non-Technical Skills

• Highly motivated with strong attention to detail.
• Ability to work effectively under tight timelines and adapt to complex, changing business environments.
• Excellent verbal and written communication skills.
• Strong analytical and problem-solving abilities.
• Excellent interpersonal skills with the flexibility to work effectively across diverse teams.
• Demonstrated cultural awareness and the ability to build consensus within a multinational organization.

The anticipated salary for this position will be $180,500 to $202,400. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes a Summer and Winter Shut-Down, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at  212 Carnegie Center Dr. Suite 510 Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-PE1

#LI-Field

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

 

Summary of Job:

 

The Senior Manager, Quality Control will play a critical role in designing, developing, and executing the operational readiness program for the start-up of the Quality Control laboratories at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC.

You will lead and enable the timely completion of key milestones to ensure production targets are achieved. This role will initially work in a greenfield environment and will transition to lead laboratory operations throughout GMP readiness, technology transfer, and facility licensure activities supporting the manufacturing of Phase III and early commercial products. You will be accountable for ensuring compliance of the Quality Control laboratories with current GxP standards and all applicable Global, Regional, and Site procedures within Kyowa Kirin's Quality Management System.

As a people leader, you will embody compassionate, people-centric leadership to guide and support our team. You will collaborate closely with others, fostering a collaborative, inclusive, and supportive environment while driving team development. Your work will reflect the organization's values and integrity in all your actions. Utilizing situational leadership and emotional intelligence, you will align diverse viewpoints, manage stakeholders, and make empathetic decisions to address individual and team needs effectively. You will also be results-oriented, ensuring that your team not only adapts to challenges but also delivers measurable outcomes that align with business objectives. Additionally, you will help teams navigate change and uncertainty with resilience and clarity, enabling them to adapt to fast-evolving, rapidly scaling environments and meet new challenges in the biotech industry with a patient-focused mindset

 

Essential Functions

Technical Skills, Knowledge, and Experience

• Provide technical leadership, collaborating cross-functionally in the site's early-stage activities, including: facility detailed design review; facility, equipment, and analytical instrument user requirements review; prioritization for implementation of equipment, instruments, and analytical methods required for facility start-up (GMP Ready/OQ Complete); and ICT efforts for developing user requirements and procuring selected electronic Quality Systems for operations (LIMS/ELN/Empower).

• Establish and maintain Quality Control procedures as applicable to the Site QMS Laboratory Controls Sub-system and develop training requirements for QC staff.

• Lead and coordinate, cross-functionally, the robust, compliant, and timely implementation of all required analytical and microbiological test methods by ensuring completion of the required steps from method development, qualification/optimization, validation, or suitability for compendial methods and/or transfer.

• Establish a Raw Materials sampling, testing, and release program in compliance with all applicable regulatory requirements (JP, USP, EP, etc.).

• Coordinate testing and reporting of laboratory results in support of the facility Environmental Monitoring and Utility Monitoring programs.

• Lead QC laboratory operations to achieve all required validation and qualification activities for the facility, equipment, analytical instruments, and computerized systems required for project commissioning and operational readiness for start-up.

• Ensure laboratory electronic systems and records are compliant with current 21 CFR Part 11 and Data Integrity (ALCOA++) requirements.

• Hire, onboard, train, and mentor QC staff per approved staffing plans.

• Lead and ensure the timely investigation of deviations, laboratory exceptions, or other cGMP issues at the site and initiate and communicate corrective and preventive actions (CAPA) for resolution, working cross-functionally.

• Establish key performance indicators for the QC laboratories (e.g., OOS, Invalid Assays, OOT, Laboratory Deviations, Testing Turnaround Times, EM Data Trends, etc.).

• Implement and manage the Contamination Control Strategy (CCS) for the site, working cross-functionally.

• Assist the Quality Site Head in identifying and qualifying contracted laboratory services and/or contingent staffing as required (Disinfectant Efficacy Studies, Mycoplasma, in vitro adventitious virus testing). Lead QC laboratory activities required to successfully respond to regulatory requests and support regulatory and internal inspections of the facility and laboratory areas.

Leadership

• Results-Oriented: Lead teams by setting clear, measurable goals and ensuring accountability for achieving key objectives. Align resources effectively, remove obstacles, and maintain focus on delivering high-quality results within established timelines.

• Empathetic Communication: Listen carefully, provide constructive feedback, and handle conflicts with care.

• Team Development: Mentor and guide team members, create growth plans, support ongoing learning, and develop the team with a patient-focused mindset.

• Inclusive Leadership: Build a diverse, respectful environment where everyone feels valued and supported.

• Supportive Environment: Encourage a positive workplace, celebrate achievements, and promote work-life balance.

• Collaboration: Lead by example, promote teamwork and respect, and ensure your actions reflect the organization's values.

• Emotional Intelligence: Manage emotions thoughtfully, make empathetic decisions with a patient-focused mindset, and remain calm under pressure.

• Change Management: Help teams navigate change with clear communication and flexibility.

• Situational Leadership: Adapt your leadership style to meet the needs of the team, offering guidance or independence as needed while keeping patient outcomes in mind.

• Stakeholder Management and Alignment Building: Work with diverse stakeholders to build alignment, guide discussions toward common goals, and ensure decisions are made with a patient-focused mindset.

 

 

Education

• Bachelor's degree in a life science or related field (minimum).

• Master's degree in a life science or related field (preferred).

 

Experience

• Five (5) or more years of management experience leading GMP biopharmaceutical Quality Control laboratories and associated support areas, including QC Sample Management, Microbiology, Raw Materials, Chemistry/Biochemistry, Stability, Bioassay, and/or Virology.

• Experience supporting the start-up and operation of a biopharmaceutical manufacturing facility is preferred.

 

Technical Skills

• Proficient in Empower, LIMS, ELN, LES, Microsoft Office Suite, Lean Lab practices, and Agile methodologies.

Non-Technical Skills

• Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and resilience, guiding teams through evolving challenges. Demonstrate strong organizational skills, attention to detail, and a solid work ethic while exhibiting cultural sensitivity and fostering alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive and engaging interactions, and building relationships with empathy and respect. Embrace continuous learning and knowledge sharing while maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Be resourceful and proactive by challenging the status quo, driving innovation, and developing creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.

 

 

During the construction and start-up phases, employees are required to wear appropriate personal protective equipment (PPE), including hard hats, safety glasses, steel-toe boots, and high-visibility vests. Once transitioned to the GMP laboratory environment, PPE will include lab coats, gloves, safety goggles, and other equipment as defined by site safety protocols.

While working at our onsite corporate facility, employees are required to wear appropriate business attire in accordance with the company's standard dress code.

If traveling between both sites, employees should be prepared to comply with the PPE and dress code requirements applicable to each location.

Reasonable accommodations will be provided as required by law.

This position is based onsite in Sanford, NC. Standard company policies regarding flexible work arrangements do not apply to this role. This is not a hybrid or remote position.

May require up to 10% domestic and limited international travel.

 

Compensation & Benefits

The anticipated annual salary for this position is $137,300 to $185,000. The actual salary offered at the commencement of employment may vary based on several factors, including, but not limited to, relevant experience, skill set, qualifications, education (including applicable licenses and certifications), job-related knowledge, geographic location, and other business and organizational needs.

The listed salary range is just one component of the overall compensation package. At Kyowa Kirin North America, we provide a comprehensive range of benefits, including:

• 401(k) with Company Match
• Annual Bonus Program (Sales Bonus for Sales Positions)
• Generous PTO and Holiday Schedule, including Summer and Winter Shut-Downs
• Sick Days
• Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drug, and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long-Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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Equal Employment Opportunity

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions.

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified individuals without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affectional preference, citizenship status, or any other characteristic protected by applicable law.

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Applicant Privacy Notice

When you apply for a position through this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), located at 510 Carnegie Center Drive, Princeton, NJ 08540 USA. The Controller can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com.

The Controller's Data Protection Officer can be contacted at usprivacyoffice@kyowakirin.com.

Your personal data will be processed for the purposes of managing the Controller's recruitment-related activities, including setting up and conducting interviews and assessments, evaluating applicants, and supporting recruitment and hiring activities. Such processing is legally permissible under Article 6(1)(f) of the General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the legitimate interests pursued by the Controller, including the solicitation, evaluation, and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States and engaged by the Controller to manage its recruitment and hiring process. Accordingly, if you are located outside the United States, your personal data will be transferred to the United States once submitted through this site. The transfer will be made using appropriate safeguards, including standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by the Controller for as long as necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, request correction or deletion of your personal data, request restriction of processing, exercise your right to data portability, and lodge a complaint with an appropriate EU supervisory authority.

If you have questions regarding the use of your personal data, please contact usprivacyoffice@kyowakirin.com.

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Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless the agency has been engaged directly by Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location. Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

 

#LI-TT1

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary of Job

As a Senior Manufacturing Operator supporting a greenfield biopharmaceutical site focused on rare disease therapies, you will be tasked to start up and execute core manufacturing operations. You will be a role model for Safety and Compliance. You will execute complex upstream and downstream processes in a GMP environment, contribute to troubleshooting and continuous improvement efforts, ensure compliance with regulatory standards, and train and mentor other manufacturing associates.

Your role will be highly collaborative, working across Engineering, Automation, and Quality teams to help build a high-performing, patient-centered manufacturing platform from the ground up. This includes hands-on involvement in equipment commissioning, process validation, and the implementation of automated systems.

As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization's values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs.

You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts

Essential Functions

Technical Skills, Knowledge, and Experience

• Execute manufacturing operations utilizing standard work on the manufacturing floor for mAb manufacturing, including weigh and dispense, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and/or UF/DF skids via PCS and MES.
• Ensure all processes are performed according to Safety and Compliance policies and procedures, current Good Manufacturing Practices (cGMP), and all other applicable requirements, including adherence to Data Integrity practices (ALCOA+).
• Adhere to operational procedures and master records and follow both written and verbal instructions from supervisors.
• Maintain accurate records, including batch records, log sheets, and other required documentation.
• Escalate any and all non-compliance events (perceived or actual) in a timely manner.
• Ensure compliant and efficient operations throughout commissioning and manufacturing operations by collaborating with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams.
• Develop operational SOPs, participate in FATs, and facilitate equipment validation and qualification in conjunction with Engineering teams.
• Identify and implement process improvements to optimize operations.
• Propose and lead initiatives to streamline workflows and eliminate waste.
• Stay current on industry trends and technologies to drive innovation in production planning.
• Utilize enterprise systems supporting manufacturing operations, including but not limited to ERP, LIMS, MES, PCS, QMS, and BMS.
• Lead on-the-floor troubleshooting and resolution of equipment, automation, and process issues and support CAPA tracking and documentation.
• Maintain cleanliness and organization of manufacturing areas through routine cleaning and preventative maintenance.
• Manage shop floor activities through 5S, Standard Work, and Kanban methodologies.
• Coordinate with Warehouse and Maintenance teams to ensure uninterrupted availability of materials, supplies, and equipment.
• Train new colleagues and junior staff in manufacturing processes, equipment operation, safety procedures, and company standards.
• Assist during technical transfer activities for new products and manufacturing processes.

Job Requirements

Education

• Bachelor's degree in a technical field (Chemical Engineering, Chemistry, Biology, or related discipline) preferred.

Experience

• Bachelor's degree plus a minimum of 4 years of relevant biopharmaceutical manufacturing experience; OR
• Associate's degree plus a minimum of 6 years of relevant biopharmaceutical manufacturing experience; OR
• High School Diploma/GED plus a minimum of 8 years of relevant biopharmaceutical manufacturing experience.
• Experience with relevant Upstream operations, including:
  • Vial Thaw/Inoculation
  • Wave Bioreactors
  • Single-Use Bioreactors (50L, 500L, 3000L)
  • Harvest Operations
• Experience with relevant Downstream operations, including:
  • Chromatography
  • Viral Inactivation
  • Viral Filtration
  • TFF Systems
  • Bulk Filling
• Direct Upstream and Downstream GMP manufacturing experience required.
• Experience supporting startup and operation of a biopharmaceutical manufacturing process preferred.

Technical Skills

• Knowledge of Agile and Lean Manufacturing principles and Standard Work.
• Proficiency with Microsoft Office applications.
• Strong problem-solving and critical-thinking skills.
• Experience authoring or editing SOPs preferred.
• Experience with electronic records and PCS software such as DeltaV, Unicorn, Ignition, or similar systems preferred.
• Ability to maintain clean manufacturing environments in accordance with GMP and safety standards.
• Ability to read and interpret technical documents.
• Ability to troubleshoot and operate production equipment.
• Ability to perform basic math and statistics.
• Strong written and verbal English communication skills

Non-Technical Skills

• Results-oriented with the ability to navigate ambiguity and drive measurable outcomes.
• Strong accountability and follow-through on commitments.
• Adaptability and resilience in a rapidly changing environment.
• Excellent organizational skills and attention to detail.
• Strong communication and interpersonal skills.
• Ability to foster collaboration across diverse teams and perspectives.
• Commitment to continuous learning and knowledge sharing.
• Growth mindset with a focus on innovation and process improvement.
• Ability to build inclusive and supportive working relationships.
• Enterprise mindset that prioritizes collective success and integrated solutions

Physical Demands

• Initial schedule will be Monday–Friday Day Shift during construction and commissioning.
• Position will transition to a 2-2-3 Day Shift schedule (7:00 AM – 7:00 PM) during manufacturing operations.
• Initially working on a construction site and ultimately in a biopharmaceutical manufacturing facility in Sanford, NC.
• Ability to lift up to 35 pounds and move heavy objects.
• Ability to stand for three or more hours while operating equipment.
• Must adhere to gowning and PPE requirements.
• Position is 100% on-site and is not eligible for remote or hybrid work
• Requires up to 10% domestic and international travel.

Compensation & Benefits

The anticipated salary for this position will be $33.00 to $45.00 per hour. The actual salary offered for this role at commencement of employment may vary based on several factors including, but not limited to, relevant experience, skill set, qualifications, education (including applicable licenses and certifications), job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America, we provide a comprehensive range of benefits including:

• 401(k) with Company Match
• Annual Bonus Program (Sales Bonus for Sales Positions)
• Generous PTO and Holiday Schedule, including Summer and Winter Shut-Downs
• Sick Days
• Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drug, and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long-Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Equal Employment Opportunity

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions.

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affectional preference, citizenship status, or any other category protected by law.

Applicant Privacy Notice

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), located at 510 Carnegie Center Drive, Princeton, NJ 08540 USA, and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com.

The Controller's Data Protection Officer can be contacted at usprivacyoffice@kyowakirin.com.

Your personal data will be processed for the purposes of managing Controller's recruitment-related activities, which include setting up and conducting interviews and assessments for applicants, evaluating and assessing results, and otherwise supporting recruitment and hiring activities. Such processing is legally permissible under Article 6(1)(f) of the General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the legitimate interests pursued by the Controller, including the solicitation, evaluation, and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States and engaged by Controller to help manage its recruitment and hiring process. Accordingly, if you are located outside the United States, your personal data will be transferred to the United States once submitted through this site. The transfer will be made using appropriate safeguards, including standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, request that your personal data be corrected or erased, request restriction of processing, exercise your right to data portability, and lodge a complaint with an EU supervisory authority.

If you have questions about our use of your personal data, please contact usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location. Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-PE1