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.
- Support IND/BLA CMC cell line or strain development document preparation.
- 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 5 years or MS with 8 years or BS with
- 10 years of 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.
- Proficient in statistical design of experiments and data analysis using JMP, Minitab, or Design-Expert software.
- Flexible and results-oriented.
Salary Range: $150,000-$160,000 annually
