Job Description
Associate Director / Director, CMC Process Development Company Overview NGM Biopharmaceuticals, Inc. is a privately held biotechnology company, focused on developing novel, life-changing medicines for people whose health and lives have been disrupted by disease. NGM Bio's 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, enable their rapid advancement into proof-of-concept studies and address high unmet patient need. Currently, NGM Bio is advancing NGM120, a
GDF15/GFRAL
antagonist antibody, to address two significant and distinct unmet needs, both of which are rooted in overactivation of the GDF15 pathway: hyperemesis gravidarum (HG) and cancer cachexia. Position Summary Join the CMC team at NGM Bio! Our team is responsible for late-stage development and cGMP manufacturing of monoclonal antibody therapeutics. In this role, you will work with the Head of CMC Development to create and execute late-stage development strategies while providing technical oversight of CDMOs for upstream/downstream process development and cGMP manufacturing. Location:
South San Francisco, CA Work Mode:
Hybrid (Minimum 2 days on-site per week) Travel:
10-20% domestic and international travel Responsibilities Serve as the technical CMC lead for a late-stage monoclonal antibody (mAb) project. Provide technical oversight of CDMOs for upstream/downstream process optimization, scale-up, cGMP Drug Substance manufacturing, process characterization, and process validation. Partner closely with Regulatory, Quality, Clinical Development, Program Management, and CDMO partners to ensure timely execution of CMC development plans. Proactively identify upstream/downstream technical and operational risks and implement mitigation strategies to support development timelines. Author, review, and approve protocols, technical reports, batch records, SOPs, and relevant sections of regulatory submissions. Ensure strict adherence to cGMP guidelines and, quality and regulatory compliance. Serve as a subject matter expert, including Person-in-Plant, during cGMP manufacturing, audits and regulatory interactions. Required Experience MS or PhD in Biotechnology, Biochemistry, Chemical Engineering, Chemistry, or a related field. 8+ years of experience in upstream and/or downstream process development for biologics, CMC operations, and CDMO management. Hands-on experience troubleshooting and optimizing biologics DS manufacturing processes and scaling up to pilot and commercial scale. Deep expertise in process characterization and process qualification for commercialization. Broad experience/working knowledge of formulation dev, drug product manufacturing (Vials/PFS) and or analytical development would be a plus. Strong scientific problem-solving and root-cause analysis skills. Extensive knowledge of GMP regulations, and CMC-related global regulatory guidelines for biologics. Strong analytical, data interpretation, communication, and regulatory documentation skills. Ability to work independently and effectively in a dynamic, fast-paced, collaborative small biotech environment. Salary Ranges At the time of posting, the wage range for this role is $180,000 - $220,000 for Associate Director level and $220,000 - $250,000 for Director level candidates located in the Bay Area. To review NGM Bio's Privacy Policy, click here .
