Director/Sr. Director, Cell Line Development
Fremont, CA
We are looking to hire a director-level candidate to join the Cell Line Development (CLD) group in a fast-paced, fast-growing CDMO. Our CLD team screens thousands of potential mammalian cell lines to find the outliers that are most productive and generate the highest quality protein. This role will focus on developing the cell bank (CHO or HEK 293) or clonally stable high-productivity CHO master cell bank (MCB) up to GMP production. A key expectation is providing extensive support in assessing and resolving client challenges, including product quality, suspected mutations or splicing issues, as well as post-translational modifications that impact protein performance. This position will require driving innovation in cutting-edge technologies to advance the CLD platform that can achieve higher cell line productivity in record development time.
Essential Duties and Responsibilities:
- Develop cell line and cell culture technologies and processes to support all phases of CMC from pre-candidate selection to commercial production.
- Transfect, screen, subclone, and characterize cell lines for the expression of product candidates.
- Utilize molecular biology techniques for vector construction, optimization, DNA sequence confirmation, etc.
- Enhance the productivity and speed of development of cell lines used for the production of mAbs and complex biologics.
- Drive innovation in cutting-edge technologies to advance the CLD platform that can achieve higher cell line productivity in record development time.
- Recommend technical solutions to aid clients in advancing projects from protein sequences to stable commercial cell lines with high purity and acceptable product quality.
- Lead CLD troubleshooting efforts.
- Represent the CLD function during potential client evaluations, including the review of documentation (proposals, statements of work, agreements, etc.), engaging in meetings, and hosting laboratory tours.
- Partner closely with cross-functional groups to ensure timely and successful completion of CLD projects and deliverables, including Business Development, Program Management, Downstream Process Development (DS PD) and Analytical & Formulation Development (AFD).
- Collaborate with Upstream Process Development (US PD) to ensure synergy and seamless transition into the media/process platform for production.
- Coordinate research cell bank (RCB) transfer and transition of client projects from CLD to US PD.
- Present data summaries and study conclusions at internal and external scientific meetings.
- Provide scientific strategy and technical/professional guidance to staff. Manage their development and build an innovative, talented team.
- Member of the Process Development Leadership Team.
Qualifications:
- BS/MS in relevant life science disciplines with 15 plus years of related experience in life science disciplines.
- Proven experience in CHO cell line development for commercial applications.
- Experience with molecular biology techniques, high throughput screening assays, and transient transfection is desired.
- Previous leadership experience in successfully managing and developing scientific staff.
- The successful candidate should be organized, self-motived, and able to work independently and as part of a team. Excellent written and verbal communication skills are required.
- Proven track record of innovation demonstrated by a consistent record of external presentations and publications.
- Ability to translate innovation into business value that benefits the pipeline.
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