Director, Technology Development Research
About The Position
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. 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.
Requirements
- Ph.D. in Biological Sciences, Immunology, Molecular Biology, Biochemistry, or closely related discipline required.
- 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.
- 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.
- 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.
Nice To Haves
- Direct experience engaging with FDA or other Health Authorities for cell therapy products is strongly preferred.
- 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.
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
