Senior Manager, Analytical Development
Join the CMC team at NGM Bio. The team is responsible for progressing NGM’s cutting edge science derived protein based therapeutics. The candidate will provide oversight for analytical development and characterization activities at CMOs and CROs in support of accelerated early and late phase development. The position requires experience in method development and validation in accordance with ICH, and a strong working knowledge of GMP regulations. Experience working on CMC teams and providing leadership for development programs is also preferred.
Core Job Responsibilities:
- Provide technical oversight of analytical development activities, such as method development, qualification and testing, at CMO and CRO sites to ensure outsourced studies are executed successfully and meet the objectives. Exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results.
- Provide leadership for analytical activities and collaborate with groups within CMC, QA, Regulatory Affairs and outside contract manufacturers and laboratories. Maintain good communications and accomplish drug development goals and objectives.
- Utilize in-house capabilities to develop and troubleshoot analytical methods such as methods based on HPLC, CE and other analytical techniques. Conduct investigations to trouble-shoot analytical or bio-process issues as needed.
- Provide analytical method development and testing for in-house process development activities.
- Serve as in-house expert on analytical technologies; train others and troubleshoot as needed.
- Author and review protocols, technical reports, SOPs as well as relevant sections of regulatory submissions.
- Define strategy and oversee execution of analytical comparability exercises, extended characterization and forced degradation studies. Interpret results and generate reports from such studies.
- Manage and analyze datasets to support setting of specification limits and trending of manufacturing and analytical data. Use current statistical approaches for data analysis.
- Ph.D. in Analytical Chemistry or related field and minimum 5 years of industry experience. Candidates with M.Sc. or B.Sc. degree will also be considered with at least 7-10 years of industry experience
- Must possess broad protein analytical chemistry knowledge and/or broad knowledge of analytical technologies supporting analysis and characterization of protein based therapeutics
- Knowledge and broad understanding of the cGMP requirements as they apply to the Biopharmaceutical industry. Good understanding of relevant USP methodologies and ICH guidelines
- Expertise in characterization of protein primary structure, post-translational modifications, degradations, identification of process and/or product related variants and impurities
- Understanding of method development and validation per FDA/ICH regulations
- Experience participating in and leading CMC teams is highly desirable
- Scientific data analysis/statistical software proficiency preferred
- GMP compliance proficiency/experience preferred
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"