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Cmc In Biotech Jobs in California (NOW HIRING)

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Director Regulatory Affairs CMC

Sonoma, CA · Hybrid

$168K - $221K/yr

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 ...

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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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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.
Associate Director, Regulatory Affairs, CMC

Associate Director, Regulatory Affairs, CMC

RAY THERAPEUTICS INC

Berkeley, CA • On-site

$175K - $195K/yr

Full-time

Posted 21 hours ago

Job description


Reporting to the Chief Regulatory Officer, the Associate Director, Regulatory Affairs will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for clinical-stage gene therapy programs. This individual will partner cross-functionally with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant, and high-quality regulatory submissions and lifecycle management activities.


Key Responsibilities include but are not limited to:

  • Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through BLA/MAA and lifecycle management)
  • Provide strategic input on manufacturing changes, comparability approaches, and control strategies
  • Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (FDA, EMA, PMDA, MHRA)
  • Lead preparation and authorship of CMC sections (Module 2.3, 3) for:
    • INDs / CTAs / Amendments
    • Briefing documents and health authority interactions
    • BLA/MAA submissions and supplements/variations
  • Ensure alignment of CMC documentation with overall regulatory strategy and program timelines
  • Oversee document quality, consistency, and compliance with global regulatory requirements
  • Serve as CMC regulatory lead for agency interactions (e.g., Type B/C meetings, Scientific Advice)
  • Prepare and review CMC briefing materials and response documents
  • Support inspection readiness activities, including coordination with Quality and Manufacturing teams
  • Provide regulatory guidance on manufacturing process development, analytical methods, specifications, and stability strategies
  • Ensure alignment across regions and maintain awareness of evolving regulatory expectations for advanced therapies

Qualifications:

  • Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred.
  • ~8–12+ years of regulatory affairs experience in biotech/pharma.
  • Experience supporting biologics and/or gene/cell therapy products strongly preferred.
  • Direct experience with IND/CTA submissions and global regulatory interactions required.
  • Deep knowledge of CMC development for biologics/ATMPs, Module 3 structure and expectations, and comparability and change management strategies.
  • Familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines)
  • Proven ability to operate effectively in a small, fast-paced biotech environment
  • Strong cross-functional leadership and influencing skills without direct authority
  • Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies

Compensation Range and Benefits:

  • For this role, the anticipated base salary range: $175,000 to $195,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
  • Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.