Associate Director / Director, CMC Process Development
About The Position
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. 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.
Requirements
- 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.
- 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.
Nice To Haves
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
