Senior Director, Cell Line Development & Biotherapeutics

Boston Institute of Biotechnology, LLC; Boston (MA); Hybrid; USD 150,000 - 160,000; Full time

Job summary

Boston Institute of Biotechnology seeks an Associate Director of Cell Line Development to lead a team optimizing mammalian cell lines and strains for therapeutic protein production. You will supervise vector development, transfections, and cell banking, while mentoring staff and managing budget.

The role requires extensive experience with CHO/HEK/NS0 systems and strong regulatory acumen, enabling collaboration with business teams and external partners.

Qualifications

• Demonstrated expertise in mammalian cell line optimization and expression technologies.
• Experience with CHO/HEK/NS0 systems; CHO-GS is highly desired.
• Ability to analyze complex molecular biology problems and drive strategic technical programs.

Responsibilities

• Lead development and optimization of mammalian cell lines and microbial strains for protein production.
• Oversee vector development, screening, transfections, media optimization, and stable cell line development.
• Manage team and budgets; mentor staff.
• Provide technical support to business and client meetings.
• Author SOPs, protocols and reports; ensure GMP/ICH compliance and regulatory adherence.
• Maintain accurate records in notebooks/datasheets.
• Represent cell-line development in conferences and publications.

Skills

Leadership

GMP/ICH knowledge

CMC experience

Statistics (JMP/Minitab/Design Expert)

Cell line development

Mammalian expression systems (CHO/HEK/

Technical writing

Budget management

Mentoring

Regulatory compliance

Cross-functional communication

Education

PhD in Molecular Biology

MS in Molecular Biology

BS in Molecular Biology

Tools

JMP

Minitab

Design Expert

Job description

The Associate Director of Cell Line Development at BIB will lead a team of scientists and associates to develop mammalian cell lines and strains for the expression of therapeutic proteins. As a core member of the Biopharmaceutical Development management team, the director will be responsible for the strategic planning and growth of cell line and strain development functions.

Responsibilities

• Lead the development and optimization of mammalian cell lines and microbial strains to produce therapeutic proteins.
• Lead the activities range from vector development, screening, transfections, media optimization, development of stable cell lines and cell banking activities.
• Manage team to perform recombinant protein characterization activities including ELISA, PCR, SDS-PAGE, western blot, etc.
• Direct cell line and strain development innovation projects, new technology evaluation/ implementation, as well as conference presentation and journal publication.
• Contribute to department and corporate strategic planning and objectives setting.
• Mentor team members and manage department budget.
• Provide technical support to business and sales team and represent cell-line development functions in client meeting.
• Author SOPs, protocols and technical reports and ensure adherence to high technical standards and compliance with applicable regulatory guidelines.
• Maintain accurate experimental records and results in laboratory notebook and/or datasheet.

Qualifications

• B.S., M.S. or Ph.D. in Molecular Biology or related discipline.
• Ph.D. with ≥11 years, M.S. with ≥14 years, or B.S. with ≥16 years industry experience.
• Demonstrated Scientific and Engineering expertise developing mammalian cell line optimization and mammalian expression technologies for the generation of monoclonal antibody and recombinant protein therapeutic products.
• Expertise working with a variety of microbial strains, cell lines and mammalian expression systems especially CHO, HEK and NS0, prior experience with CHO-GS system is highly desired.
• Experience with bi-specific cell line development is highly preferred.
• Able to analyze complex molecular biology problems, develop strategic initiatives and execute technical programs, and make recommendations to executive management.
• Ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects is required.
• Strong knowledge in PAT technologies, GMP / ICH guidelines and CMC experience.
• Advanced cross-functional communication, written and presentation skills.
• Effective organizational and staff management skills.
• Proficient in statistical design of experiment and data analysis using JMP, Minitab, or Design Expert software.
• Flexible and results oriented.

Salary Range: $150,000-$160,000 annually

Please email your resume and why you believe you are a good fit for this position directly to [e-mail] Thank you!

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BIB is a full service CDMO partner offering cGMP and non-GMP mammalian, microbial, gene therapy and cell therapy services.