- Job Type: Full-Time
- Function: Life Sciences R&D/Engineering
- Industry: Biotechnology
- Post Date: 09/19/2022
- Website: ngmbio.com
- Company Address: 333 Oyster Point Blvd, South San Francisco, CA, 94080
About NGM BioNGM Biopharmaceuticals is a privately-held drug discovery company committed to identifying transformational medicines that dramatically improve human health. Based on emerging human clinical and genetic observations, the company has devised several innovative experimental approaches to discover new therapies for the treatment of metabolic andcardiovascular diseases.
NGM Biopharmaceuticals, Inc. is focused on discovering and developing novel, life-changing medicines for people whose health and lives have been disrupted by disease. Our biology-centric drug discovery approach aims to seamlessly integrate interrogation of complex disease-associated biology and protein engineering expertise to unlock proprietary insights that are leveraged to generate promising product candidates and enable their rapid advancement into proof-of-concept studies. As explorers on the frontier of life-changing science, we aspire to operate one of the most productive research and development engines in the biopharmaceutical industry and our research team has a track record of producing an average of one new IND candidate per year. Today the company has seven disclosed programs, including four in Phase 2 or 2b studies, across three therapeutic areas: cancer, retinal diseases, and liver and metabolic diseases.
The CMC team at NGM Bio is responsible for progressing NGM’s cutting edge science derived protein-based therapeutics. We are looking for a Senior Manager to lead development of potency methods in support of accelerated early and late phase large molecule development projects. The role requires experience in bioassay development, including both ELISA and cell-based methods. The individual in this role will also have an opportunity to be the overall lead for analytical development and quality control on clinical projects; therefore, a general knowledge of HPLC and other physicochemical characterization methods is a plus.
- Serve as in-house expert on potency assays. Lead and manage development of appropriate assays to be utilized as characterization and release testing methods to demonstrate biological activity of active ingredients in drug substance and drug product materials. Provide technical expertise and leadership for selecting most appropriate scientific basis for individual potency assays. Provide expertise and leadership for constructing methods in compliance with regulatory requirements of biological potency assays, and for their validation and maintenance.
- Provide technical oversight of all analytical development activities, such as method development, method validation 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.
- Collaborate with cell line development, upstream and downstream process development, formulation and drug product development groups within CMC, Quality, Regulatory Affairs and outside contract manufacturers and laboratories. Maintain good communications and accomplish drug development goals and objectives.
- Author and review protocols, technical reports, SOPs as well as relevant sections of regulatory submissions.
- 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 Biochemistry or related field.
- Minimum of 7 years’ post-graduate experience which includes at least 5 years of industry experience.
- Expertise and experience in cell-based bioassay development and validation.
- Understanding and experience in applying regulatory requirements for constructing and validating biological potency assays.
- Protein analytical chemistry knowledge and knowledge of analytical technologies supporting analysis and characterization of protein based therapeutics.
- Understanding of the cGMP requirements as they apply to the Biopharmaceutical industry. Good understanding of relevant USP methodologies and ICH guidelines.
- Understanding of method development and validation per FDA/ICH regulations.
- Proficiency in scientific data analysis/statistical software.
- Experience in managing and/or working at CRO/CMO.