Associate Director, Analytical Cell Line Engineering & Bioassay Development

Takeda • Lexington, MA

1d

About The Position

About the role: You will report to the Head of Analytical Development, Biologics (Late Stage), and establish and lead the Analytical Cell Line Engineering function, with direct people leadership responsibility. This role leads the execution of the scientific strategy and owns implementation of analytical cell line generation across the biologics portfolio. Operating at the interface between Discovery and Development, the role translates mechanism of action (MoA) understanding into phase-appropriate potency strategies, implements these as early-stage potency assays, and ensures alignment and continuity into late-stage through collaboration with the potency team. Analytical cell lines developed within this function serve as critical reagents for bioassay development. The Associate Director is accountable for delivering a scalable capability that enables potency assessment, functional characterization, and a defensible analytical control strategy. This role establishes analytical cell line engineering as a core capability supporting regulatory submissions and product lifecycle management through effective team leadership, execution discipline, and cross-functional alignment. How you will contribute:

Requirements

• Ph.D. in a relevant life sciences discipline with at least 8 years of industry experience in cell line engineering and/or bioassay development for biologics.
• Expertise in stable mammalian cell line engineering, including vector design, transfection or transduction, clonal isolation, genomic and copy number characterization, and flow cytometry-based analysis.
• Experience developing cell-based potency assays supporting pre-clinical or clinical development.
• Demonstrated 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 experience managing scientific teams and delivering results in a matrixed, cross-functional environment.
• Strong project and resource management skills, with the ability to drive execution across multiple programs.

Responsibilities

• Define and execute the strategy for analytical cell line engineering aligned with product MoA.
• Establish and implement technical approaches for vector design, stable integration, clone selection, expression stability, and lifecycle management of analytical cell banks.
• Lead and develop a team responsible for analytical cell line generation, development of bioassays (including cell-based potency assays and other functional assays), and development of residual impurity assays; set scientific and performance expectations.
• Ensure clear linkage between MoA, cell line engineering, assay performance, and analytical control strategy, including assessment of functional relevance.
• Represent Analytical Development on cross-functional teams and contribute to program strategy and regulatory positioning.
• Ensure compliance with applicable GxP requirements, documentation standards, and data integrity principles; author and review CMC documentation and support regulatory submissions and health authority interactions.
• Build, mentor, and develop a high performing scientific team and elevate enterprise capability in cell line engineering and bioassay design through technical standards, training, and governance.
• Manage resource planning, prioritization, and allocation to ensure delivery against program timelines and portfolio priorities.
• Drive operational excellence, including continuous improvement in workflows, timelines, and quality of deliverables.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees