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Cmc Operations Jobs in California (NOW HIRING)

Retro

CMC Regulatory Lead

Redwood City, CA

$200K - $240K/yr

We're hiring an experienced CMC Regulatory Lead to own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work. As one of the earliest members of the ...

Retro

CMC Regulatory Lead

Redwood City, CA · On-site

$200K - $240K/yr

We're hiring an experienced CMC Regulatory Lead to own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work. As one of the earliest members of the ...

Retro

CMC Regulatory Lead

Redwood City, CA

$200K - $240K/yr

We're hiring an experienced CMC Regulatory Lead to own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work. As one of the earliest members of the ...

AbbVie

Director, RA CMC

Irvine, CA

$161K - $212K/yr

Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life ...

AbbVie

Director, RA CMC

Irvine, CA · On-site

$160K/yr

Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the ...

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All JobsCmc Operations JobsCmc Operations Jobs in California

Cmc Operations information

What are CMC operations?

CMC operations refer to the activities involved in Chemistry, Manufacturing, and Controls within the pharmaceutical industry, focusing on the development, production, and quality assurance of drug products. Professionals in this field ensure compliance with regulatory standards and often work with laboratory techniques, documentation, and process validation.

What are CMC jobs?

CMC jobs refer to roles in Chemistry, Manufacturing, and Controls within the pharmaceutical and biotech industries. These positions involve developing, validating, and overseeing manufacturing processes, ensuring compliance with regulatory standards, and preparing documentation for drug approval. Skills in quality assurance, regulatory knowledge, and technical expertise are often required.

Is CMC a good career path?

CMC Operations involves managing chemistry, manufacturing, and controls processes in the pharmaceutical industry, requiring knowledge of regulatory standards and quality assurance. It offers opportunities for career growth, especially for those with a background in science, engineering, or quality management. The role often involves collaboration across departments and adherence to strict compliance requirements.

Are CMC jobs in high demand?

CMC operations roles are in steady demand within the pharmaceutical and biotech industries due to the need for compliance, quality control, and process management in drug development. These positions often require knowledge of regulatory standards and experience with manufacturing processes, making them valuable for candidates with relevant skills and certifications.

What is the difference between Cmc Operations vs CMC Regulatory Affairs?

AspectCmc OperationsCMC Regulatory Affairs
Required CredentialsBachelor's degree in life sciences, engineering, or related field; experience in manufacturing or quality controlDegree in life sciences, pharmacy, or related; regulatory certifications often preferred
Work EnvironmentManufacturing plants, quality control labs, supply chainRegulatory agencies, corporate offices, compliance teams
Industry UsageManufacturing, quality assurance, supply chain managementRegulatory submissions, compliance, documentation
Common Search/ComparisonYesYes

While both Cmc Operations and CMC Regulatory Affairs are essential in the pharmaceutical industry, Cmc Operations focuses on manufacturing, quality control, and supply chain processes. In contrast, CMC Regulatory Affairs handles regulatory submissions, compliance, and documentation to ensure products meet legal standards. Understanding these differences helps professionals and employers align roles with their expertise and industry needs.

What are popular job titles related to Cmc Operations jobs in California? For Cmc Operations jobs in California, the most frequently searched job titles are:
What job categories do people searching Cmc Operations jobs in California look for? The top searched job categories for Cmc Operations jobs in California are:
What cities in California are hiring for Cmc Operations jobs? Cities in California with the most Cmc Operations job openings:
Cmc Operations jobs near you
Associate Director / Director, CMC Process Development

Associate Director / Director, CMC Process Development

NGM Biopharmaceuticals

South San Francisco, CA • On-site

$180K - $220K/yr

Full-time

Re-posted 6 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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