Director, Analytical Development - On-site Cell Therapy

Meet Life Sciences Ltd.; Cambridge (MA); In loco; USD 185.000 - 240.000; Tempo pieno

Descrizione del lavoro

Meet Life Sciences Ltd. is seeking a Director of Analytical Development to establish and execute the analytical development strategy for an iPSC-derived cell therapy pipeline. You will lead a small team, partner with Regulatory, Quality, R&D, CDOs, and testing labs, and support method development across the product lifecycle.

This on-site role involves collaboration with external partners as needed and shaping analytical capabilities to advance toward clinical development and commercialization.

Competenze

• Bachelor's degree or higher in a life sciences field with extensive industry experience.
• Leadership experience in analytical development within cell therapy or biotechnology.

Mansioni

• Lead analytical strategy, priorities, roadmaps, and risk-based assay plans.
• Manage, recruit, train, mentor, and develop Analytical Development staff.
• Build analytical methods and potency testing strategies for cell therapy products.
• Execute laboratory-based analytical development activities as needed.
• Oversee SOPs, test methods, development reports, qualifications, and supporting procedures.
• Transfer in-process, release, and characterization methods to external manufacturing and testing partners.
• Resolve complex quality-control testing issues during clinical production.
• Develop and approve analytical source documents and support CMC regulatory submissions.
• Partner with Regulatory teams on agency responses and analytical strategies.
• Evaluate and select external testing and manufacturing partners.
• Drive continuous improvement, operational excellence, and analytical capability development.
• Support budgets, resource forecasts, capital planning, and departmental business cases.

Conoscenze

Analytical Development Leadership

Cell Therapy

iPSC-derived products

Potency Assays

Flow Cytometry

RT-PCR

ddPCR

External Partner Management

Formazione

Bachelor's degree in life sciences

Master's degree in life sciences

PhD in biotechnology or related field

Strumenti

RT-PCR

ddPCR

Flow Cytometry

Descrizione del lavoro

Meet Life Sciences Ltd. is seeking a Director of Analytical Development to establish and execute the analytical development strategy for an iPSC-derived cell therapy pipeline. You will lead a small team, partner with Regulatory, Quality, R&D, CDOs, and testing labs, and support method development across the product lifecycle.

This on-site role involves collaboration with external partners as needed and shaping analytical capabilities to advance toward clinical development and commercialization.