NGM Biopharmaceuticals, Inc. is a clinical stage biotech company dedicated to discovering and developing the next generation of medicines for the treatment of serious diseases. Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates and other distinguished researchers to form a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine. To date, NGM Bio has generated a pipeline of seven drug candidates in various stages of development targeting liver, metabolic and ophthalmic diseases and cancer. The most advanced drug candidate, NGM282, is entering Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH). NGM’s strategic collaboration with Merck, which was extended to March 2022, will continue to provide us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
NGM currently has a Senior Scientist position open in the cell line development & engineering (CLD&E) group. The CLD&E group is responsible for developing GMP cell lines that facilitate the progressing of NGM’s cutting edge science derived protein based therapeutics into clinical trials. As a Senior Scientist in the CLD&E group, the candidate will be a key contributor to refining our approaches used currently in the cell line development workflow, as well as developing a next generation in-house cell line fed-batch screening and production processes. In addition, the candidate will provide oversight for cell line development activities for pipeline projects within NGM and at CMOs. The position requires in-depth knowledge on cell culture process and media development, and experience in construction of mammalian cell lines suitable for GMP manufacturing. Successful candidate shall be an accomplished technical leader with a proven track record, who can operate in a multidisciplinary, collaborative, fast paced environment.
Required Skills
- Responsible for planning, coordinating and managing the activities in pipeline projects involving development of GMP cell lines at NGM and at CMOs
- Perform media component analysis and development studies to select suitable conditions for both cell line screening and cell culture process
- Provide technical oversight in CLD or upstream related activities including process development and process transfer.
- Hands on execution of cell line development activities for pipeline projects
- Contribute to the improvements of current cell line development platform and to the development of a new cell line and cell culture platform
- Design studies and interpret results of development, troubleshooting and process characterization experiments
- Author and review protocols, technical reports, batch records, SOPs and CMC sections of regulatory submissions.
- Conduct root cause investigations and identify solutions to resolve CLD and media development related issues.
- Represent CLD functional area within the CMC team; communicate and collaborate with members from CMC, QA, Regulatory Affairs, Clinical Development within NGM and with CMOs and CROs to achieve project goals and timelines
- The position requires close collaboration with other CMC functions. Work together with Upstream, Downstream, Formulation and Analytical Development areas, including providing data and materials to support efforts in Upstream, Downstream, Formulation and Analytical development
Required Experience
- Ph.D. in Biotechnology, Biology, Chemical Engineering or other relevant life science disciplines with more than 4 years’ relevant industry experience. Candidates with M.Sc. or B.Sc degree will also be considered with sufficient industry experience and demonstrated ability to lead a broad USP scope.
- In-depth knowledge in mammalian cell culture process development, including the impact of media components on cell culture performance is required
- Proficiency in state of the art development of mammalian cell lines used in GMP production of protein based therapeutic candidates
- Experience in developing and implementing high throughput CLD approaches is a plus
- Experience in and understanding the requirements of GMP manufacturing is preferred.
- Experience in managing GMP cell banking and testing (MCBs and WCBs) is strongly preferred
- Knowledge and broad understanding of the cGMP requirements and relevant regulatory guidelines, including requirements for cell bank manufacturing and testing.
- Experience participating in and leading cross functional teams such as CMC teams is a plus
- Excellent written and oral communication skills
- Ability to work in a fast-paced environment, to multitask and manage multiple projects
- Ability to independently and rapidly make decisions based on data, scientific knowledge and sound judgement
- Proficiency in scientific data analysis/statistical software and experience with Design of Experiment is a plus
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package.
Interested applicants should apply through the NGM Biopharmaceuticals website: http://www.ngmbio.com/careers/#SilkroadFrame