Associate Director

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.
• Able 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.