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Cmc In Biotech Jobs in California (NOW HIRING)

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable ... Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or ...

Kite Pharma

Manager, Regulatory Affairs CMC

El Segundo, CA · On-site

$133K - $172K/yr

Degree in life sciences, biotechnology, pharmaceutical sciences, or related field * Experience in Regulatory Affairs CMC within biotech or pharmaceutical industry * Experience with cell therapy / CAR ...

Kite Pharma

Manager, Regulatory Affairs CMC

Oceanside, CA · On-site

$133K - $172K/yr

Degree in life sciences, biotechnology, pharmaceutical sciences, or related field * Experience in Regulatory Affairs CMC within biotech or pharmaceutical industry * Experience with cell therapy / CAR ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site

$180K - $210K/yr

Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable ... Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or ...

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Cmc In Biotech information

How is CMC used in pharmaceuticals?

In the context of CMC (Chemistry, Manufacturing, and Controls) in biotech jobs, CMC involves developing and controlling the processes for producing pharmaceuticals, ensuring product quality, safety, and efficacy. It includes activities like formulation development, process validation, and stability testing, often requiring knowledge of regulatory requirements and laboratory skills.

What is the difference between Cmc In Biotech vs Formulation Scientist?

AspectCmc In BiotechFormulation Scientist
Required CredentialsBachelor's or Master's in Life Sciences, Good Manufacturing Practice (GMP) knowledgeBachelor's or Master's in Pharmacy, Chemistry, or related field; GMP experience
Work EnvironmentLaboratories, manufacturing facilities, regulatory settingsLaboratories, R&D departments, manufacturing units
Employer & Industry UsageBiotech companies, pharmaceutical firms, contract manufacturing organizationsPharmaceutical companies, biotech firms, contract labs

While both roles operate within the biotech and pharmaceutical industries, Cmc In Biotech focuses on Chemistry, Manufacturing, and Controls documentation and regulatory compliance, whereas Formulation Scientists primarily develop and optimize drug formulations. Cmc In Biotech professionals ensure regulatory submissions are complete, while Formulation Scientists work on creating effective drug delivery systems. Both roles often collaborate but serve distinct functions within the product development pipeline.

What is a CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes involved in developing and producing a pharmaceutical product. CMC professionals ensure that drugs are manufactured consistently, meet quality standards, and comply with regulatory requirements, often working with laboratory techniques, quality assurance, and regulatory submissions.

What is the highest paying job in biotech?

In biotech, senior executive roles such as Chief Scientific Officer (CSO) or Vice President of Research typically have the highest salaries, often exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and leadership skills in research and development environments.

What are CMC jobs?

CMC jobs in biotech refer to roles involved in Chemistry, Manufacturing, and Controls activities, which ensure the quality, safety, and efficacy of biopharmaceutical products. These positions often require knowledge of regulatory requirements, laboratory skills, and experience with process development and validation. CMC professionals play a critical role in drug development and manufacturing compliance.
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Infographic showing various Cmc In Biotech job openings in California as of July 2026, with employment types broken down into 1% As Needed, 83% Full Time, 4% Part Time, 1% Temporary, 4% Contract, and 7% Summer. Highlights an 82% Physical, 2% Hybrid, and 16% Remote job distribution.
Associate Director, CMC Regulatory

Associate Director, CMC Regulatory

Revolution Medicines

Redwood City, CA • Hybrid

Other

Re-posted 2 days ago

Job description

The Opportunity:

As part of our expanding organization, we seek a strategic and hands-on Associate Director, CMC Regulatory who will be responsible for executing CMC regulatory strategies to support clinical development, marketing authorizations, and lifecycle management of RevMed's pipeline compounds/products.

This role involves coordinating and preparing CMC sections of regulatory submissions to support RevMed's global clinical trials, including programs executed in collaboration with external partners, marketing applications, and post approval changes. The ideal candidate should have a strong understanding of global regulatory requirements and be able to guide CMC teams throughout the drug development process.

Primary Responsibilities:

  • Develop, lead, and implement global CMC regulatory strategies to support clinical development through registration and post-marketing activities.

  • Provide CMC regulatory leadership for global clinical trial execution, including RevMedsponsored trials and incoming/outgoing external collaborations, ensuring appropriate CMC strategy, documentation, crossreferencing, and health authority compliance across sponsors, regions, and development stages.

  • Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.

  • Serve as the CMC regulatory representative on project teams and provide CMC regulatory support for the clinical development of the investigational product(s) and ensure applicable regulatory requirements are appropriately met.

  • Collaborate with corporate regulatory team, CMC SMEs and/or CROs to identify. regional/country-specific CMC requirements to support global applications, and to drive the CMC submission timelines in order to meet business objectives.

  • Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle.

  • Lead and/or contribute to internal process improvements, SOP development, and organizational initiatives to support globalization of RevMed's products.

  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders.

Required Skills, Experience and Education:

  • BA/BS degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline.

  • Minimum of 10 years of experience in pharmaceutical/biotech drug development, including at least 5 years in global CMC regulatory affairs.

  • Experience in leading CMC related global clinical and commercial submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM).

  • Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.

  • Demonstrated experience in effective collaboration with internal and external stakeholders.

  • Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment

  • Experience with small molecules (NCEs) and managing complex CMC technical documentation.

  • Excellent communication and stakeholder management skills, including experience working cross-functionally and with external partners.

  • Ability to operate effectively in a fast-paced, matrixed, global environment.

Preferred Skills:

  • An advanced degree (PhD, PharmD, MSc) in Pharmaceutical Science, Chemistry, Chemical Engineering or related field is desirable. #LI-Hybrid #LI-CT1

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