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Cmc Chemistry Manufacturing Control Jobs (NOW HIRING)

TekWissen LLC

CMC Writer

Paramus, NJ · On-site

$45 - $50/hr

A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in ... and quality control. * Authors a range of clinical documents, including regulatory documents ...

Watton Hall

CMC Specialist

CMC Specialist The CMC Specialist in Regulatory Affairs is responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory submissions for pharmaceutical products.

Cardinal Health

$31.50 - $40.41/hr

We currently have a career opening for a Scientist I - CMC What Chemistry, Manufacturing and ... Familiarity with core CMC concepts (e.g., manufacturing, control strategy, change management) and ...

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Cmc Chemistry Manufacturing Control information

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How much do cmc chemistry manufacturing control jobs pay per hour?

As of Jul 26, 2026, the average hourly pay for cmc chemistry manufacturing control in the United States is $31.59, according to ZipRecruiter salary data. Most workers in this role earn between $25.72 and $36.54 per hour, depending on experience, location, and employer.

What are some common challenges faced in a CMC (Chemistry, Manufacturing, and Controls) role, and how can professionals effectively address them?

Professionals in CMC roles often encounter challenges such as ensuring regulatory compliance across global markets, managing tight timelines for product development, and maintaining robust documentation for quality assurance. To address these, effective communication with cross-functional teams—including R&D, regulatory affairs, and manufacturing—is essential. Staying up-to-date with evolving regulatory guidelines and fostering a proactive approach to risk management can also help anticipate and mitigate issues before they impact project timelines or product quality.

What are the key skills and qualifications needed to thrive as a CMC (Chemistry, Manufacturing, and Controls) specialist, and why are they important?

To thrive as a CMC specialist, you need a strong background in chemistry, pharmaceutical sciences, or chemical engineering, often with an advanced degree and experience in regulatory submissions. Familiarity with analytical instrumentation, quality management systems, and regulatory guidelines such as ICH, FDA, and EMA requirements is essential. Strong project management, attention to detail, and effective communication skills are crucial for coordinating cross-functional teams and ensuring compliance. These skills are vital to ensure product quality, regulatory approval, and successful commercialization in the pharmaceutical industry.

What is the difference between Cmc Chemistry Manufacturing Control vs Cmc Quality Control?

AspectCmc Chemistry Manufacturing ControlCmc Quality Control
Primary FocusEnsuring manufacturing processes meet specifications and regulatory standardsTesting and verifying product quality through analysis
ResponsibilitiesProcess validation, batch documentation, complianceSampling, testing, release of products
Work EnvironmentManufacturing facilities, laboratories, regulatory settingsLaboratories, quality assurance departments
Required CredentialsScientific background, GMP knowledge, regulatory familiarityAnalytical skills, laboratory certifications, scientific education

While both roles are essential in pharmaceutical manufacturing, Cmc Chemistry Manufacturing Control focuses on overseeing manufacturing processes and compliance, whereas Cmc Quality Control emphasizes testing and verifying product quality. Understanding these distinctions helps clarify career paths and job expectations within the industry.

What is CMC (Chemistry, Manufacturing, and Controls) in the pharmaceutical industry?

CMC, or Chemistry, Manufacturing, and Controls, refers to the critical processes and documentation required to ensure that pharmaceutical products are consistently produced and controlled according to quality standards. It covers everything from the chemical makeup of the drug, the manufacturing process, and quality control measures, to packaging and labeling. CMC is essential for regulatory submissions, as it demonstrates that a product is safe, effective, and of high quality. Regulatory agencies like the FDA and EMA require detailed CMC information for new drug approvals and ongoing compliance.
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What job categories do people searching Cmc Chemistry Manufacturing Control jobs look for? The top searched job categories for Cmc Chemistry Manufacturing Control jobs are:
Cmc Chemistry Manufacturing Control jobs near you
Infographic showing various Cmc Chemistry Manufacturing Control job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 78% Full Time, 18% Part Time, 1% Temporary, and 2% Contract. Highlights an 85% Physical, 1% Hybrid, and 14% Remote job distribution, with an average salary of $65,713 per year, or $31.6 per hour.

Director, Regulatory - CMC

Stark Pharma Solutions Inc

San Francisco, CA • On-site

$176K - $233K/yr

Contractor

Posted 26 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