Associate Director/Director - Upstream Process Development
NGM Biopharmaceuticals, Inc. is a private 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 six drug candidates in various stages of development, including NGM282 that recently demonstrated proof-of-concept in a Phase 2 study in non-alcoholic steatohepatitis (NASH). We have many more in preclinical development. In 2015, we entered into a broad, strategic collaboration with Merck that will 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 leadership position open in our CMC team. The team is responsible for progressing NGM’s cutting edge science derived protein based therapeutics. As a Director/Associate Director in Upstream Process Development, the candidate will provide oversight for upstream technical activities from process development to cGMP manufacturing at CMOs in support of accelerated Phase 1 development and late stage development/commercialization. In addition, the candidate will drive the development and optimization of an in house upstream platform process at NGM. The position requires in-depth knowledge of mammalian cell culture process development and cGMP manufacturing. Successful candidate shall be an accomplished technical leader with a proven track record, who can operate in a multidisciplinary, collaborative, fast paced environment.
- Responsible for planning, coordinating and managing the activities of the Upstream sub-function within CMC
- Provide technical oversight on all upstream related activities including process development, process transfer and cGMP manufacturing
- Drive and oversee tech transfer, Tox material production and cGMP clinical material manufacturing at CMO sites
- Design studies and interpret results of development, troubleshooting and process characterization experiments
- Set effective development and manufacturing strategies using current state of the art biomanufacturing technologies and approaches
- Lead the development of an in-house mammalian cell culture platform process at NGM; activities include developing, optimizing and transferring the upstream process to CMO sites
- Manage and analyze datasets of upstream development and manufacturing runs, including manufacturing and analytical data. Use current statistical approaches for data analysis
- Author and review protocols, technical reports, batch records, SOPs and CMC sections of regulatory submissions
- Conduct root cause investigations and identify solutions to resolve upstream related issues
- Lead cross functional project teams and represent Upstream functional area; take a lead role in strategic decisions for development programs; 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
- Manage and guide members of the USP CMC group, to ensure delivery of technical objectives, effective collaboration and career development for each group member
- The position requires close collaboration with other CMC functions. Support the Cell Line Development function on in-house cell line development activities. Work together with Downstream, Formulation and Analytical Development areas, including providing data and materials to support efforts in Downstream, Formulation and Analytical development
- Ph.D. in Chemical Engineer, Biotechnology or other relevant life science disciplines with more than 8 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 and manufacturing is required
- Strong hands-on experience with both bench scale bioreactor platforms and large scale (≥1000L) bioreactor operations are required
- Knowledge and broad understanding of the cGMP requirements and relevant regulatory guidelines, including requirements for upstream and cell bank manufacturing and testing
- Experience participating in and leading cross functional teams such as CMC teams
- Excellent written and oral communication skills
- People management experience
- 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
- Knowledge of both mammalian and microbial expression systems is strongly preferred
- Proficiency in scientific data analysis/statistical software and experience with Design of Experiment is a plus
- Significant travel is required
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.
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