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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 position?

A CMC (Chemistry, Manufacturing, and Controls) position in biotech involves overseeing the development, manufacturing, and quality control of biopharmaceutical products. Professionals in this role ensure that products meet regulatory standards and are produced consistently, often requiring knowledge of GMP (Good Manufacturing Practice) and regulatory guidelines.

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, producing, and ensuring the quality of a biopharmaceutical product. CMC professionals are responsible for regulatory compliance, process validation, and quality assurance to meet industry standards and facilitate product approval.

What is the CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes ensuring the quality, safety, and efficacy of a biotech product throughout development and production. Professionals in this field often work on regulatory submissions, quality assurance, and process validation to meet industry standards.

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Cmc In Biotech jobs near you
Infographic showing various Cmc In Biotech job openings in California as of August 2026, with employment types broken down into 1% As Needed, 94% Full Time, 1% Part Time, and 4% Contract. Highlights an 76% Physical, 4% Hybrid, and 20% Remote job distribution.

Director, CMC Regulatory

Corvus Pharmaceutical

San Francisco, CA • On-site

$230 - $270/hr

Other

Posted 20 days ago

Job description

Corvus Pharmaceutical is a clinical-stage biopharmaceutical company developing novel therapies with the potential to significantly improve the treatment of immune diseases and cancer. Our lead program, Soquelitnib, is a first-in-class, oral therapy that selectively inhibits ITK to modulate and control parallel signaling pathways in the immune system.

Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC 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 small molecule 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.

Role and Responsibilities
  • Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through NDA/MAA and lifecycle management)
  • Provide strategic input and regulatory guidance on manufacturing changes, comparability approaches, and control strategies
  • Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (e.g., FDA, EMA, Health Canada, PMDA)
  • Lead preparation and authorship of CMC sections (Module 2.3, 3) for INDs/CTAs/Amendments
  • Lead preparation of CMC briefing documents and health authority interactions
  • Prepare and submit NDA/MAA and associated supplements/variations
  • Ensure alignment of CMC documentation with overall regulatory strategy and program timelines
  • Oversee document quality, consistency, and compliance with global regulatory requirements
  • Represent regulatory in change control assessments
  • Support inspection readiness activities in collaboration with Quality and Manufacturing teams
Qualifications and Education Requirements
  • Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred
  • Minimum of 10+ years of regulatory affairs experience in biotech/pharma
Preferred Skills
  • Experience supporting small molecules required (familiarity with additional modalities desirable)
  • Experience with IND/CTA, NDA/MAA compilation and submissions
  • Deep knowledge of CMC development for small molecules, 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

Salary Range: $230,000 to $270,000

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