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Manager Downstream Process Development Scientist Jobs in California

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Cell Line Development

Tustin, CA

As a Cell Line Development Scientist , you will play a critical role in establishing high ... Partner with Upstream and Downstream Process Development and Analytical teams to deliver integrated ...

Amgen

Process Development Senior Scientist

Thousand Oaks, CA

$96K - $131K/yr

... downstream processing for oral solid dosage forms. * Experience supporting oral solid dosage form ... Excellent interpersonal and verbal/written communication skills with demonstrated ability to manage ...

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Infographic showing various Manager Downstream Process Development Scientist job openings in California as of June 2026, with employment types broken down into 81% Full Time, and 19% Part Time. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.
Associate Director / Director, CMC Process Development

Associate Director / Director, CMC Process Development

NGM Biopharmaceuticals

South San Francisco, CA • Hybrid

$180K - $220K/yr

Other

Posted 8 days ago

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.

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