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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 ...

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Cmc In Biotech information

What is the highest paying job in the biotech industry?

In the biotech industry, senior roles such as Vice President of Research and Development or Chief Scientific Officer typically have the highest salaries, often exceeding several hundred thousand dollars annually. These positions require extensive experience, advanced degrees, and leadership skills, and they oversee strategic research initiatives and regulatory compliance.

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 drug production, ensuring quality, safety, and efficacy. It includes activities like formulation development, process validation, and stability testing, which are essential for regulatory approval and manufacturing consistency.

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 difference between CMC and GMP?

In biotech, CMC (Chemistry, Manufacturing, and Controls) refers to the documentation and processes ensuring a drug's quality, safety, and efficacy, while GMP (Good Manufacturing Practice) is a set of regulations that govern how drugs are produced to meet quality standards. CMC involves developing and controlling the product, whereas GMP ensures the manufacturing environment and procedures comply with quality requirements. Both are essential for regulatory approval and quality assurance in biotech roles like CMC specialists.
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Cmc In Biotech jobs near you
Infographic showing various Cmc In Biotech job openings in California as of June 2026, with employment types broken down into 78% Part Time, and 22% Contract. Highlights an 82% Physical, 3% Hybrid, and 15% Remote job distribution.

Director Regulatory Affairs CMC

Meet Life Sciences

Alameda, CA • Hybrid

$174K - $229K/yr

Other

Posted 29 days ago

Job description

Director, Regulatory CMC (Hybrid – San Francisco Bay Area)


We are partnering with a well-funded, clinical-stage biotechnology company with a diversified pipeline spanning both biologics and small molecule therapeutics. The organization is advancing multiple programs across early and late-stage development and is building out its Regulatory CMC leadership to support global filings and accelerate programs toward commercialization.

This is a high-impact, strategic leadership role for someone who thrives at the intersection of regulatory strategy, CMC development, and cross-functional program execution in a fast-paced, science-driven environment.


The Director, Regulatory CMC will lead global CMC regulatory strategy and execution across multiple programs, including biologics and small molecules. This individual will serve as a key interface between Regulatory Affairs, CMC, Quality, Technical Operations, and external partners to ensure alignment with global regulatory expectations and successful IND/CTA, BLA, and NDA submissions.


This is a hybrid role based in the San Francisco Bay Area, requiring on-site collaboration several days per week.


Key Responsibilities

  • Lead global Regulatory CMC strategy across clinical and late-stage development programs (biologics and small molecules)
  • Author, review, and oversee high-quality CMC sections for INDs, IMPDs, CTAs, BLAs, and NDAs
  • Provide strategic regulatory guidance on CMC development plans, comparability strategies, process changes, and lifecycle management
  • Act as primary CMC regulatory liaison with global health authorities, including FDA and EMA
  • Partner closely with Process Development, Manufacturing, Analytical, and Quality teams to ensure regulatory alignment
  • Support regulatory responses to agency questions, deficiencies, and inspection readiness activities
  • Drive regulatory risk assessments and mitigation strategies for complex CMC issues
  • Contribute to development of regulatory policies, templates, and best practices across the organization
  • Monitor evolving global regulatory guidance impacting CMC strategy and submissions


Qualifications

  • Advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related field (PhD preferred)
  • 10+ years of experience in Regulatory Affairs CMC within biotech or pharma
  • Demonstrated experience supporting both biologics and small molecule development programs
  • Strong track record of successful IND/CTA filings and NDA/BLA submissions
  • Deep understanding of CMC regulatory requirements across US, EU, and other global regions
  • Experience interacting directly with regulatory agencies (FDA, EMA, and/or other health authorities)
  • Strong cross-functional leadership skills in matrixed, fast-paced environments
  • Excellent written and verbal communication skills with the ability to influence senior stakeholders


Why This Role

  • Opportunity to shape CMC regulatory strategy across a dual-modality pipeline
  • High visibility role reporting into senior regulatory leadership
  • Strong pipeline momentum with multiple clinical-stage assets
  • Collaborative, science-driven culture with significant growth trajectory


If interested, please reach out to tanya.kochan@meetlifesciences.com

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