Head Of Cell Line Development (Director) The Director, Head Of Cell Line Development (CLD) provides leadership for mammalian cell line development to enable a biologics portfolio including monoclonal antibodies, bi-specifics, and adjacent molecular formats. This role sets CLD strategy, leads a team of cell and molecular biologists, and delivers high-performing production cell lines. The role enables programs from early development through IND/IMPD, with lifecycle support for commercial cell lines, as needed. This role is accountable for oversight of GMP cell banking activities (MCB/WCB readiness and governance).Define CLD vision, platform strategy, and roadmap aligned to portfolio demand (including complex/next-gen antibody formats).Lead, coach, and develop a team of ~10 responsible for clinical cell line delivery and technology evaluation; drive hiring, capability development, and succession planning. Own functional budget, cell line timelines, and vendor governance for CRO/CDMO support where used. Provide technical and operational oversight of end-to-end mammalian cell line development: vector/transfection strategy, selection systems, single-cell cloning, clone screening, stability assessment, and candidate cell line nomination. Ensure fit-for-purpose characterization packages (growth, productivity, stability, and product quality) in collaboration with upstream process development. Lead risk-based strategies for difficult-to-express and complex molecules (e.g., bi-specifics), including mitigation plans and decision criteria. Ensure robust documentation of cell line history, clonality rationale, traceability, and data integrity to support filings and audits. Contribute to regulatory submissions and responses (e.g., IND/IMPD; later-stage support as needed).Accountable for cell banking strategy and execution, including readiness for MCB/WCB generation. Ensure clear, compliant handoffs and documentation for cell bank production (internal or external), including batch records/data packages and deviations/investigations support as applicable. Lead evaluation, selection, and implementation of new CLD technologies (host cell/selection systems, single-cell tools, automation, analytics, digital/AI-enabled screening, etc.). Work closely with upstream process development to ensure platform fit of changes/optimization to the host cell line/vectors and/or workflow. Build external collaborations with technology providers and academic/industry partners to maintain competitive CLD capabilities.
Skills and qualifications:
PhD in Cell Biology, Molecular Biology, Biochemical Engineering, Biotechnology, or a related scientific discipline with 10+ years of relevant industry experience; or Master's degree with 12+ years ; or Bachelor's degree with 15+ years Recognized expert in Cell Line Development, with a demonstrated track record of delivering clinical production cell lines with strong documentation and tech transfer packages. Possesses deep expertise in cell biology, host cell engineering, and expression vector design. Recognized as a subject matter expert with broad awareness of emerging technologies and trends across the industry. Strong understanding of how CLD decisions impact product quality and manufacturability, particularly for bi-specifics and complex proteins. Recognized as an expert in influencing, able to manage in a matrix environment, collaborate across functions, and communicate effectively to senior stakeholders. Extensive experience in managing and coaching a team of scientists at all levels and establishing strong career development plans. Experience supporting commercial cell lines and lifecycle management (e.g., investigations, comparability/change control inputs) with an understanding of the regulatory and quality requirements for establishment of MCB/WCBs and IND/BLA submissions. Demonstrated success implementing automation/high-throughput screening and collaborating with analytical colleagues to improve cycle times. Recognized expert in troubleshooting, able to solve strategic problems, and coaching others.
Takeda Compensation and Benefits Summary:
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Cambridge - Binney StU.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. For information about our benefits, please click here.
EEO Statement:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
