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Cmc In Biotech Jobs (NOW HIRING)

Amgen, Inc.

Sr Associate Regulatory Affairs - CMC

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest ... The RA CMC Senior Associate will interface with the Amgen global, international, site and ...

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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 the United States as of July 2026, with employment types broken down into 1% As Needed, 85% Full Time, 1% Part Time, 4% Contract, and 9% Summer. Highlights an 82% Physical, 2% Hybrid, and 16% Remote job distribution.

Director, Regulatory - CMC

Stark Pharma Solutions Inc

San Francisco, CA • On-site

$176K - $233K/yr

Contractor

Re-posted 13 days ago

Job description

Job Title: Director, Regulatory CMC

Location: San Francisco, CA (Onsite – 4 days/week)

Industry: Biotechnology / Pharmaceutical

Job Summary

We are seeking an experienced Director, Regulatory CMC (Chemistry, Manufacturing, and Controls) to join a growing biotech organization. This role will lead regulatory strategy and execution for CMC activities across development programs, with exposure to both small molecules and biologics.

The ideal candidate will bring strong expertise in global regulatory requirements and play a key role in supporting product development, submissions, and lifecycle management.

Key Responsibilities

  • Lead and develop CMC regulatory strategies to support clinical development and commercialization
  • Prepare and review regulatory submissions (INDs, NDAs, BLAs, amendments, and supplements)
  • Ensure compliance with FDA, EMA, and global regulatory requirements
  • Collaborate cross-functionally with CMC, Quality, Manufacturing, and Clinical teams
  • Provide regulatory guidance on process development, manufacturing changes, and product lifecycle management
  • Support interactions with regulatory agencies, including meeting preparation and responses
  • Oversee preparation and review of Module 3 (CMC) documentation
  • Stay current with evolving regulatory requirements and industry trends

Required Qualifications

  • Bachelor’s degree in Life Sciences, Chemistry, or related field (advanced degree preferred)
  • 10+ years of experience in Regulatory Affairs (CMC) within biotech/pharma
  • Strong experience with IND, NDA, BLA submissions
  • Experience with both small molecules and/or biologics (both preferred)
  • Deep understanding of global regulatory guidelines (FDA, EMA, ICH)
  • Excellent communication, leadership, and stakeholder management skills