Associate Director, Analytical Cell Line Engineering & Bioassay Development
Takeda
5 hours ago
Remote friendly (Lexington, MA)
United States
$154,400 - $242,550 USD yearly
Clinical Research and Development
About the role:
- Report to the Head of Analytical Development, Biologics (Late Stage); establish and lead the Analytical Cell Line Engineering function with direct people leadership.
- Lead execution of the scientific strategy and own analytical cell line generation across the biologics portfolio; translate MoA into phase-appropriate potency strategies and early-stage potency assays.
- Ensure alignment and continuity into late stage through collaboration with the potency team.
- Deliver a scalable capability enabling potency assessment, functional characterization, and a defensible analytical control strategy to support regulatory submissions and product lifecycle management.
How you will contribute:
- Define and execute the strategy for analytical cell line engineering aligned with product MoA.
- Establish technical approaches for vector design, stable integration, clone selection, expression stability, and lifecycle management of analytical cell banks.
- Lead/develop a team for analytical cell line generation, bioassay development (cell-based potency and other functional assays), and residual impurity assay development; set scientific/performance expectations.
- Ensure linkage between MoA, cell line engineering, assay performance, and analytical control strategy.
- Represent Analytical Development on cross-functional teams; contribute to program strategy and regulatory positioning.
- Ensure GxP compliance, documentation standards, and data integrity; author/review CMC documentation; support regulatory submissions and health authority interactions.
- Build/mentor/develop the scientific team and elevate enterprise capability through standards, training, and governance.
- Manage resource planning/prioritization/allocation; drive operational excellence and continuous improvement.
Skills and qualifications:
- Ph.D. in a relevant life sciences discipline with at least 8 years industry experience in cell line engineering and/or bioassay development for biologics.
- Expertise in stable mammalian cell line engineering (vector design; transfection/transduction; clonal isolation; genomic/copy number characterization; flow cytometry).
- Experience developing cell-based potency assays for pre-clinical or clinical development.
- Ability to define technical strategy and influence senior cross-functional stakeholders.
- Working knowledge of regulatory expectations for potency methods and analytical control strategies.
- Proven leadership managing scientific teams in matrixed, cross-functional environments.
- Strong project and resource management skills across multiple programs.
Benefits (if explicitly listed):
- Eligible for short-term and/or long-term incentives; medical/dental/vision; 401(k) with match; disability and life insurance; tuition reimbursement; paid volunteer time off; company holidays; well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Location (listed): Lexington, MA
- Report to the Head of Analytical Development, Biologics (Late Stage); establish and lead the Analytical Cell Line Engineering function with direct people leadership.
- Lead execution of the scientific strategy and own analytical cell line generation across the biologics portfolio; translate MoA into phase-appropriate potency strategies and early-stage potency assays.
- Ensure alignment and continuity into late stage through collaboration with the potency team.
- Deliver a scalable capability enabling potency assessment, functional characterization, and a defensible analytical control strategy to support regulatory submissions and product lifecycle management.
How you will contribute:
- Define and execute the strategy for analytical cell line engineering aligned with product MoA.
- Establish technical approaches for vector design, stable integration, clone selection, expression stability, and lifecycle management of analytical cell banks.
- Lead/develop a team for analytical cell line generation, bioassay development (cell-based potency and other functional assays), and residual impurity assay development; set scientific/performance expectations.
- Ensure linkage between MoA, cell line engineering, assay performance, and analytical control strategy.
- Represent Analytical Development on cross-functional teams; contribute to program strategy and regulatory positioning.
- Ensure GxP compliance, documentation standards, and data integrity; author/review CMC documentation; support regulatory submissions and health authority interactions.
- Build/mentor/develop the scientific team and elevate enterprise capability through standards, training, and governance.
- Manage resource planning/prioritization/allocation; drive operational excellence and continuous improvement.
Skills and qualifications:
- Ph.D. in a relevant life sciences discipline with at least 8 years industry experience in cell line engineering and/or bioassay development for biologics.
- Expertise in stable mammalian cell line engineering (vector design; transfection/transduction; clonal isolation; genomic/copy number characterization; flow cytometry).
- Experience developing cell-based potency assays for pre-clinical or clinical development.
- Ability to define technical strategy and influence senior cross-functional stakeholders.
- Working knowledge of regulatory expectations for potency methods and analytical control strategies.
- Proven leadership managing scientific teams in matrixed, cross-functional environments.
- Strong project and resource management skills across multiple programs.
Benefits (if explicitly listed):
- Eligible for short-term and/or long-term incentives; medical/dental/vision; 401(k) with match; disability and life insurance; tuition reimbursement; paid volunteer time off; company holidays; well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Location (listed): Lexington, MA