Associate Director / Director, CMC Process Development

Responsibilities

• Serve as the technical CMC lead for a late-stage monoclonal antibody (mAb) project.
• Provide technical oversight of CDMOs for upstream/downstream process development, 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.

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.
• Broad experience/working knowledge of formulation development, drug product manufacturing (Vials/PFS), and 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.

Qualifications

Must have:

• 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.
• Knowledge of GMP regulations, and CMC-related global regulatory guidelines for biologics.
• Strong analytical, data interpretation, communication, and regulatory documentation skills.

Skills

• Technical leadership and project management skills.
• Strong problem-solving and root-cause analysis skills.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a dynamic environment.

Benefits

NGM Biopharmaceuticals offers a comprehensive benefits package including:

• Health insurance
• Retirement savings plan
• Flexible spending accounts
• Employee assistance program
• Comprehensive wellness programs

Pay

$180,000 - $220,000 for Associate Director level and $220,000 - $250,000 for Director level candidates located in the Bay Area.

Schedule

Hybrid (Minimum 2 days on-site per week)

Travel

10–20% domestic and international travel