Manager / Senior Manager, Downstream Process Development
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 an opening for a highly motivated individual to join our CMC team. The team is responsible for progressing NGM’s cutting edge science derived protein therapeutics from the research lab to the clinic. As a Manager in Downstream Process Development, the candidate will provide oversight for downstream technical activities at CMOs in support of early stage clinical development and will lead the design and execution of process characterization activities for multiple downstream unit operations in preparation of Process Performance Qualification and BLA submission. In addition, the candidate will contribute to the development and optimization of the NGM downstream platform process. The position requires in-depth knowledge and hands-on experience of purification development and cGMP manufacturing. Successful candidate shall be independent, team oriented, and efficient in multitasking.
Core Job Responsibilities:
- Provide technical oversight on all downstream related activities including process development, process transfer, and cGMP manufacturing
- Serve as person-in-plant to oversee and support tech transfer, tox material production, and drug substance manufacturing at CMO sites.
- Optimize the in-house purification platform process and implement process changes at CMOs.
- Manage and analyze datasets of development and manufacturing runs to communicate results and recommendations.
- Oversee the planning, execution and analysis of Process Characterization and Process Performance Qualification activities, including statistical design and data analysis, risk assessment and parameter range and criticality determinations to establish effective control strategies for commercial processes.
- Author and review protocols, technical reports, batch records, SOPs, as well as relevant sections of regulatory submissions.
- Support deviation investigations and identify CAPAs to resolve downstream related issues.
- Ability to work collaboratively with members from CMC, QA, and Regulatory Affairs to achieve project goals and timelines.
- Ph.D. in Chemical Engineering, Biotechnology or equivalent disciplines with more than 4 years’ relevant industry experience. Candidates with M.Sc. or B.Sc degree will also be considered with more than 7 years’ relevant industry experience. Job level may be adjusted based on experience.
- In-depth knowledge in downstream process development and cGMP manufacturing is required.
- Experience with purification, filtration, and UFDF equipment is required.
- Late stage development or commercial support is highly desired with experience in process characterization, DOE, and validation packages
- Knowledge and broad understanding of the cGMP requirements and relevant regulatory guidelines, including requirements for viral clearance testing.
- Experience in participating in and leading CMC teams is highly desirable
- Excellent written and oral communication skills
- Ability to work in a fast-paced environment, to multitask, and manage multiple projects
- Ability to independently make decisions based on data, scientific knowledge and sound judgement
- Knowledge of microbial purification is a plus
- Proficiency in statistical software and experience with Design of Experiment is a plus.
- Ability to travel domestically and internationally
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 click "Apply"