Head of Cell Line Development

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.