Sr. Principal Scientist - Cell Line Development

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

Sr. Principal Scientist, Cell Line Development

Our firm is currently partnered with a growing biopharmaceutical development organization seeking an Associate Director of Cell Line Development to lead its mammalian cell line and microbial strain development capabilities.

This individual will lead a team of scientists and associates responsible for developing high-performing expression systems for monoclonal antibodies, recombinant proteins, and other therapeutic products. As a key member of the Biopharmaceutical Development leadership team, the Associate Director will help shape the strategic growth of the cell line development function while providing technical leadership across client programs.

Key Responsibilities

• Lead the development and optimization of mammalian cell lines and microbial strains for therapeutic protein production.
• Oversee activities spanning vector construction, screening, transfection, media optimization, stable cell line development, and cell banking.
• Manage recombinant protein characterization activities, including ELISA, PCR, SDS-PAGE, and Western blot.
• Provide scientific and operational leadership to a team of scientists and research associates.
• Support the preparation of cell line and strain development documentation for IND, BLA, and broader CMC submissions.
• Drive innovation projects, evaluate emerging technologies, and oversee the implementation of new platforms and capabilities.
• Represent the cell line development function in client meetings and provide technical support to business development and commercial teams.
• Contribute to departmental strategy, capability expansion, resource planning, and budget management.
• Author and review SOPs, protocols, technical reports, and development documentation.
• Ensure programs meet applicable regulatory expectations, technical standards, and project timelines.
• Mentor and develop team members while fostering a collaborative, results-oriented environment.

Qualifications

• S., M.S., or Ph.D. in Molecular Biology, Cell Biology, Biochemistry, Biotechnology, or a related scientific discipline.
• D. with at least 5-7 years, M.S. with 8-11 years, or B.S. with at least 12-16 years of relevant industry experience.
• Demonstrated expertise in mammalian cell line development and expression technologies supporting monoclonal antibody and recombinant protein therapeutics.
• Hands-on experience with mammalian expression systems such as CHO, HEK, and NS0.
• Experience with the CHO-GS platform is highly desirable.
• Experience developing cell lines for bispecific antibodies or other complex biologics is strongly preferred.
• Familiarity with microbial strain development and optimization.
• Strong understanding of PAT technologies, GMP expectations, ICH guidelines, and CMC development.
• Experience supporting IND/BLA documentation and regulatory submissions.
• Proficiency in statistical design of experiments and data analysis using JMP, Minitab, Design-Expert, or comparable software.
• Demonstrated ability to lead technical programs, solve complex development challenges, and make strategic recommendations to senior leadership.
• Strong team leadership, project management, organizational, and cross-functional communication skills.