Director, CMC Analytical Development
NGM Biopharmaceuticals, Inc. is a biopharmaceutical 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 build a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine that has a track record of generating one new IND candidate per year. NGM’s current pipeline of clinical-stage programs consists of five drug candidates targeting liver and metabolic diseases, retinal diseases and cancer. The most advanced drug candidate, aldafermin (NGM282), is in Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH) and is wholly-owned by NGM. Another drug candidate, NGM621, is in a Phase 2 study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). NGM’s strategic collaboration with Merck, with a current term running to March 2022, provides us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
CORE JOB RESPONSIBILITIES
- Lead the analytical development function within the company, responsible for all aspects of CMC analytics
- Drive development and implementation of protein and antibody analytical methods in the laboratory and at CMOs
- Refine analytical strategy for commercialization projects to enable BLA content and commercial launch preparation, including comprehensive set of specifications, method development and validation, extended characterization of product, characterization of biological activity, analytical comparability studies, forced degradation, isolation and characterization of product variants, identification, assessment and risk management of critical quality attributes and stability studies
- Set and implement effective analytical strategy for early stage clinical development projects
- Guide analytical development group members in defining, executing and analyzing development studies. Ensure scientifically sound approaches for studies performed in-house and at CMOs. Ensure generation of high-quality data summary presentations and reports
- Manage, mentor and foster career development of analytical development group members; manage resourcing of projects and project assignments of group members
- Drive and oversee cross-site and cross-company method transfer activities
- Contribute to laboratory and manufacturing investigations, develop and execute experiments in the laboratory as needed
- Collaborate effectively with other functions, including cell line development, drug substance process development, formulation and drug product process development, combination device development, protein engineering, pre-clinical toxicology, clinical development, quality assurance, regulatory affairs, business development and finance
- May serve as cross functional team leader for high priority and complex CMC projects and initiatives; identifies and pursues opportunities to enhance practices
- Author and review protocols, technical reports, method SOPs, method qualification/validation documents, analytical sections of IND/CTA and BLA/MAA regulatory submissions
- Provide updates and make recommendations to senior management
- PhD Pharmaceutical Sciences, Chemistry, Chemical Engineering, Bioengineering, with more than 15 years’ relevant industry experience. Candidates with B.S./M.S. may also be considered with demonstrated leadership track record in analytical development (job level can be adjusted based on experience)
- Comprehensive knowledge of state-of-the-art analytical and potency technologies, such as LC-MS, various HPLC modes and detections, CE-SDS, peptide map, ELISA, qPCR, cell-based assays, HIAC, DSC, fluorescence spectroscopy
- Significant history working in biologics analytical development and/or quality control laboratories
- History with commercialization projects, successful track record of BLA projects is desired
- Knowledgeable of drug substance and drug product development and stability programs
- Knowledge and broad understanding of cGMP requirements as they apply to the Biopharmaceutical industry. Good understanding of relevant USP methodologies and ICH guidelines
- Experience working with CMOs, CROs, contract service providers and consultant contributors
- Experience working with and leading cross functional teams such as CMC teams and clinical development teams
- Experience in small molecule analytical development is a plus, but the role requires primarily protein-based biologics experience
- Outstanding written and verbal communication skills
- Must be able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation.
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"
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