Head of Cell Line Development
Takeda
August 26, 2026
On-site
Cambridge, MA
$177,000 - $278,080 USD yearly
Operations
Head of Cell Line Development (Director)
Responsibilities:
- Define CLD vision, platform strategy, and roadmap aligned to portfolio demand.
- Lead, coach, and develop a team (~10) for clinical cell line delivery and technology evaluation.
- Own functional budget, cell line timelines, and vendor governance (CRO/CDMO support as needed).
- Provide end-to-end oversight of mammalian cell line development: vector/transfection strategy, selection systems, single-cell cloning, clone screening, stability assessment, and nomination.
- Ensure fit-for-purpose characterization packages (growth, productivity, stability, product quality) with upstream process development.
- Lead risk-based strategies for difficult-to-express/complex molecules (e.g., bi-specifics).
- Ensure robust documentation (cell line history, clonality rationale, traceability, data integrity) to support filings/audits; contribute to IND/IMPD submissions.
- Accountable for cell banking strategy/execution, including GMP readiness for MCB/WCB generation and compliant handoffs/documentation.
- Evaluate and implement new CLD technologies (host cell/selection systems, single-cell tools, automation, analytics, digital/AI-enabled screening) and ensure platform fit.
- Build external collaborations with technology providers and academic/industry partners.
Qualifications:
- Recognized expert in Cell Line Development with a track record delivering clinical production cell lines and strong tech transfer packages.
- Deep expertise in cell biology, host cell engineering, and expression vector design.
- Strong understanding of CLD impact on product quality/manufacturability (esp. bi-specifics/complex proteins).
- Expert in influencing; manage in a matrix environment; collaborate cross-functionally with senior stakeholder communication.
- Extensive experience leading/coaching scientists and driving career development.
- Experience supporting commercial cell lines and lifecycle management (investigations, comparability/change control) including regulatory/quality requirements for MCB/WCB and IND/BLA.
- Demonstrated success with automation/high-throughput screening and improving cycle times.
- Expert troubleshooting; solves strategic problems and coaches others.
Responsibilities:
- Define CLD vision, platform strategy, and roadmap aligned to portfolio demand.
- Lead, coach, and develop a team (~10) for clinical cell line delivery and technology evaluation.
- Own functional budget, cell line timelines, and vendor governance (CRO/CDMO support as needed).
- Provide end-to-end oversight of mammalian cell line development: vector/transfection strategy, selection systems, single-cell cloning, clone screening, stability assessment, and nomination.
- Ensure fit-for-purpose characterization packages (growth, productivity, stability, product quality) with upstream process development.
- Lead risk-based strategies for difficult-to-express/complex molecules (e.g., bi-specifics).
- Ensure robust documentation (cell line history, clonality rationale, traceability, data integrity) to support filings/audits; contribute to IND/IMPD submissions.
- Accountable for cell banking strategy/execution, including GMP readiness for MCB/WCB generation and compliant handoffs/documentation.
- Evaluate and implement new CLD technologies (host cell/selection systems, single-cell tools, automation, analytics, digital/AI-enabled screening) and ensure platform fit.
- Build external collaborations with technology providers and academic/industry partners.
Qualifications:
- Recognized expert in Cell Line Development with a track record delivering clinical production cell lines and strong tech transfer packages.
- Deep expertise in cell biology, host cell engineering, and expression vector design.
- Strong understanding of CLD impact on product quality/manufacturability (esp. bi-specifics/complex proteins).
- Expert in influencing; manage in a matrix environment; collaborate cross-functionally with senior stakeholder communication.
- Extensive experience leading/coaching scientists and driving career development.
- Experience supporting commercial cell lines and lifecycle management (investigations, comparability/change control) including regulatory/quality requirements for MCB/WCB and IND/BLA.
- Demonstrated success with automation/high-throughput screening and improving cycle times.
- Expert troubleshooting; solves strategic problems and coaches others.