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

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