Senior Director, Cell Line Development & Innovation

EPM Scientific; Massachusetts; On-site; USD 190,000 - 270,000; Full time

Job summary

EPM Scientific is partnering with a biopharmaceutical development organization to recruit an Associate Director of Cell Line Development. The role leads mammalian cell line and microbial strain development for antibody and recombinant protein products, guiding a team and shaping strategy.

The incumbent will drive platform improvements, oversee regulatory submissions readiness, and ensure timelines and standards meet GMP expectations. Strong leadership and communication are essential.

Qualifications

• Ph.D./M.S./B.S. with substantial industry experience in cell line development.
• Demonstrated expertise in mammalian expression systems (CHO, HEK, NS0).
• Experience enabling IND/BLA submissions and CMC development.

Responsibilities

• Lead development and optimization of mammalian cell lines and microbial strains for therapeutic protein production.
• Oversee vector construction, screening, transfection, media optimization, and cell banking.
• Manage recombinant protein characterization: ELISA, PCR, SDS-PAGE, Western blot.
• Provide scientific leadership to scientists and research associates.
• Support creation of documentation for IND, BLA, and CMC submissions.
• Drive innovation and oversee new platforms and capabilities.
• Represent cell line development in client meetings and with BD teams.
• Contribute to strategy, resource planning, and budget management.
• Author and review SOPs, protocols, and technical reports.

Skills

Mammalian cell line development

Leadership

GMP knowledge

IND/BLA support

Statistical design of experiments

Education

Ph.D. in Molecular Biology/Cell Biology/Biochemistry/Biotechnology

M.S. in a related field

B.S. in a related field

Tools

JMP

Minitab

Design-Expert

Job description

EPM Scientific is partnering with a biopharmaceutical development organization to recruit an Associate Director of Cell Line Development. The role leads mammalian cell line and microbial strain development for antibody and recombinant protein products, guiding a team and shaping strategy.

The incumbent will drive platform improvements, oversee regulatory submissions readiness, and ensure timelines and standards meet GMP expectations. Strong leadership and communication are essential.