- Job Type: Full-Time
- Function: Life Sciences QA/QC
- Industry: Biotechnology
- Post Date: 08/01/2022
- 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 Senior Manager, QA Operations will be responsible for important functions of the Quality Unit, including but not limited to batch record review and releases, stability protocol / report review, deviation, change control and CAPA review and approval. The successful candidate must have a strong GMP background and be knowledgeable in biologics, with clinical phase I - III experience preferred.
The individual will assist in the development and continual improvement of GMP quality systems at NGM Biopharmaceuticals in compliance with appropriate regulations, guidelines and procedures.
Job duties and responsibilities
- Manage all lot release activities including but not limited to Drug Substance, Drug Product, Placebos, Co-Medications and Investigational Drug packed and labeled for Clinical Trials.
- Review and improve systems and procedures for lot review and lot release as necessary.
- Manage GMP issues related to investigational drugs including but not limited to temperature excursions of investigational drugs, shipping deviations, and technical complaints.
- Provide oversight of internal and external quality records, including investigation reports and CAPAs. Identify and implement appropriate corrective actions based on investigative findings.
- Participate in cross-functional project teams and serve as QA representative. Interface with internal and external stakeholders to address and resolve product and process related issues.
- Establish, maintain and report metrics to evaluate the Quality performance of CMOs and internal KPIs. Prepare Quality Metrics for the Quality Management Review.
- Work with the Quality team as required to support the activities of the team including, but not limited to initializing and improving policies and SOPs, supporting daily activities.
- Work with the Quality team and other stakeholders to further develop NGM’s Quality System.
Experience and Education
- Prior experience in disposition of clinical products and CMO Quality oversight.
- Strong biologics GMP background and good technical understanding of manufacturing processes for biologics.
- Ability to multi-task, shift priorities under tight timelines and handle multiple projects simultaneously.
- Ability to identify opportunities for improvement of Quality Systems and take appropriate action.
- Strong knowledge of FDA guidelines and GMP regulations, QA principles, industry practices and standards.
- Knowledge of Quality Risk Management tools.
- Excellent written and verbal communication skills, detail-oriented with commitment to accuracy.
- 8+ years QA experience in the pharmaceutical / biological industry and a BS degree. Advanced Degree preferred.
- Ability to work in team-oriented environment.