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Cmc In Biotech Jobs (NOW HIRING)

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA · On-site

$161K - $213K/yr

Lead and execute global CMC regulatory strategies for assigned programs across all phases of ... in the biotech or pharmaceutical industry, with a minimum of 7 years in Regulatory Affairs ...

Atomic

CMC Consultant

D. preferred) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field. * 10+ years of drug development experience with demonstrated leadership of CMC strategy in biotech ...

Atomic

Drug CMC Lead

$150K - $215K/yr

... CMC strategy in biotech/pharmaceutical settings. * Expertise in formulation development, analytical method development/validation, stability programs, GMP manufacturing, and quality compliance.

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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 41% Locum Tenens, 1% As Needed, 50% Full Time, 1% Part Time, 4% Contract, and 3% Summer. Highlights an 82% Physical, 3% Hybrid, and 15% Remote job distribution.

Director, CMC Regulatory

Corvus Pharmaceutical

South San Francisco, CA • On-site

Full-time

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, Manufacturi ng, 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

• NDA/MAA and supplements/variations preparation and submissions

• 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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