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Cmc Jobs (NOW HIRING)

Rhythm Pharmaceuticals

Director, Regulatory CMC

Boston, MA · On-site

$182K - $275K/yr

This individual contributor role will execute regulatory CMC plans and support implementation of filing strategies for assigned programs. As part of the growing and dynamic regulatory affairs team ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D Global Regulatory Affairs and within Global Operations business needs. This role promotes strong ...

Immunedge Inc

Head of CMC

Redwood City, CA · On-site

$277K - $416K/yr

Reporting to the EVP of R&D, the Head of CMC owns the technical strategy and the hands-on execution that carries our molecules from research-grade material to GMP clinical supply and all related ...

Us tech Solutions

CMC Regulatory Manager

Morristown, NJ · On-site

CMC Manager Duration: 12 Months Location: Morristown, NJ 07962 The CMC Documentation Team is responsible for the development of Chemistry, Manufacturing and Control (Module 3) documentation for the ...

Revolution Medicines

Director, Global CMC Regulatory

$153K - $202K/yr

The Director, Global CMC Regulatory is a strategic leadership role responsible for developing, driving, and executing global commercial CMC regulatory strategies to secure and maintain marketing ...

Calico

Director, Regulatory CMC

South San Francisco, CA · On-site

$275K - $280K/yr

The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to accelerate clinical ...

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

$300 - $380/hr

Position Reporting to the EVP of R&D, the Head of CMC owns the technical strategy and the hands-on execution that carries our molecules from research-grade material to GMP clinical supply and all ...

Atomic

Drug CMC Lead

$150K - $215K/yr

We are seeking a versatile and experienced CMC Lead to lead our drug development and manufacturing. Position Overview: Reporting to the CEO, you will own and execute the Chemistry, Manufacturing ...

Us tech Solutions

CMC Regulatory Manager

Morristown, NJ · On-site

CMC Manager Duration: 12 Months Location: Morristown, NJ 07962 The CMC Documentation Team is responsible for the development of Chemistry, Manufacturing and Control (Module 3) documentation for the ...

Korsana Biosciences

VP, CMC

Waltham, MA · On-site

$300 - $340/hr

The Vice President of CMC (Chemistry, Manufacturing, and Control) at Korsana Biosciences will develop, implement, and execute CMC strategy in support of a best-in-class portfolio of preclinical and ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D Global Regulatory Affairs and within Global Operations business needs. This role promotes strong ...

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Cmc information

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How much do cmc jobs pay per hour?

As of Aug 23, 2026, the average hourly pay for cmc in the United States is $31.24, according to ZipRecruiter salary data. Most workers in this role earn between $19.23 and $36.54 per hour, depending on experience, location, and employer.

What is a CMC?

CMC stands for Chemistry, Manufacturing, and Controls. CMC professionals are responsible for ensuring that pharmaceutical products are developed, manufactured, and controlled in compliance with regulatory standards. Their work includes overseeing formulation development, analytical testing, process validation, and documentation required for regulatory submissions. CMC experts play a critical role in bringing safe and effective drugs to market by ensuring product quality and consistency throughout the development and manufacturing process.

What are some common challenges faced by a CMC professional when coordinating between R&D, manufacturing, and regulatory teams?

CMC professionals often encounter challenges in aligning the timelines and priorities of R&D, manufacturing, and regulatory teams. Ensuring that product development meets both regulatory requirements and manufacturing feasibility can require extensive cross-functional communication and problem-solving. Additionally, adapting to evolving regulatory guidelines and integrating feedback from multiple stakeholders demands strong project management skills. Overcoming these challenges is essential for maintaining project momentum and ensuring successful product submissions.

What are the key skills and qualifications needed to thrive as a CMC professional, and why are they important?

To thrive as a CMC professional, you need expertise in pharmaceutical sciences, regulatory requirements, and process development, typically supported by a degree in chemistry, pharmacy, or a related field. Familiarity with regulatory submission systems, analytical tools, and quality management software is essential. Strong project management, attention to detail, and effective communication are vital soft skills for coordinating cross-functional teams and ensuring compliance. These skills and qualities are critical to guarantee the safety, efficacy, and regulatory approval of pharmaceutical products.

What is the difference between CMC vs Regulatory Affairs Specialist?

AspectCMCRegulatory Affairs Specialist
Required CredentialsBachelor's degree in life sciences, chemistry, or pharmacy; often additional certifications in pharmaceutical sciencesBachelor's degree in life sciences, pharmacy, or related field; certifications in regulatory affairs are common
Work EnvironmentLaboratories, manufacturing sites, and R&D departments within pharmaceutical companiesRegulatory agencies, pharmaceutical companies, and consulting firms
Industry UsageFocuses on drug development, manufacturing, and quality documentationFocuses on compliance, submissions, and communication with regulatory bodies

While both CMC and Regulatory Affairs Specialists work within the pharmaceutical industry, CMC professionals primarily handle the chemistry, manufacturing, and control aspects of drug development. Regulatory Affairs Specialists focus on ensuring compliance with regulations and managing submissions to authorities. Both roles often collaborate but serve distinct functions in bringing a drug to market.

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Cmc jobs near you
Infographic showing various Cmc job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 18% Part Time, and 3% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $64,986 per year, or $31.2 per hour.

Associate Director, Regulatory CMC

Summit Therapeutics

Palo Alto, CA • On-site

Full-time

Re-posted 19 days ago

Job description

About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
  • HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
  • HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
  • HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)
  • HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Hybrid: 4 days On-Site at one of our physical locations: Palo Alto, CA, Princeton, NJ, Miami, FL
Overview of Role:
The Associate Director, Regulatory Affairs, CMC, is responsible for coordinating and preparing high-quality global regulatory filings. This role will provide regulatory strategy input, and oversee preparation of regulatory submissions in collaboration with other stakeholders including CMC, Supply Chain and QA. The Associate Director is responsible for providing regulatory guidance on Chemistry, Manufacturing and Controls (CMC) regulatory activities for assigned product(s) in coordination with key internal stakeholders. This role will manage regulatory CMC aspects of compounds (large molecules) through all phases of development and provide strategic and operational management of preparation and maintenance of CMC regulatory filings to support ongoing clinical activities as well as marketing applications.
Role and Responsibilities:
  • Planning, development and finalization of high-quality Regulatory CMC documents to meet global regulatory requirements.
  • Represent Regulatory CMC in project teams and provide strategic regulatory CMC input to ensure successful product development
  • Works closely with the CMC, Supply Chain, Quality and Regulatory Affairs team in developing global regulatory strategies and preparing submissions for the approval for assigned products.
  • Manage internal review and approval process for CMC related submissions
  • Coordinate the planning and preparation of Health Authority meeting requests, briefing books and responses to Health Authority information requests
  • Manage timelines for assigned projects in alignment with company goals
  • Review CMC sections of regulatory submissions (IND, IMPD, BLA etc) for compliance with regulatory requirements and alignment with company strategies.
  • RA support in interactions with Health Authorities (HA), as
  • Identify areas of continuous process improvement and engaging RA teams and key stakeholders as necessary.
  • Support in providing interpretation of global CMC regulations and guidelines, to Summit personnel for assigned programs
  • Provide regulatory impact assessment to CMC changes and deviations and plan, prepare and manage any related regulatory submissions as necessary.
  • Escalate issues that affect regulatory compliance, promptly to CMC RA Management
  • Maintain up to date knowledge of global regulations and guidances pertaining to CMC issues
Experience, Education and Specialized Knowledge and Skills:
  • Bachelor's Degree in Chemistry, Pharmacy, Engineering, Biochemistry or related science required and Master's Degree or other advanced degree preferred
  • 6 or More Years Regulatory CMC experience and/ or related Pharmaceutical industry experience required.
  • Experience in biologics required
  • Thorough and extensive knowledge of FDA and EU regulations required
  • Experience in preparation of CMC sections for regulatory submissions (IND, IMPD, BLA, MAA, Amendments, Supplements etc)
  • A good understanding of IND, CTA, BLA and MAA
  • Proficiency in Mandarin Chinese (spoken and written) is highly desirable
  • Proficient user of standard of Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
  • Strong computer and database skills
  • Attention to detail, accuracy and
  • Clear and concise oral and written communication skills
  • Excellent organizational skills
  • Critical thinking, problem solving, ability to work
  • Must be able to effectively multi-task and manage time-sensitive and highly confidential
  • Communicate effectively and articulate complex ideas in an easily understandable way
  • Prioritize conflicting
  • Work in a fast-paced, demanding and collaborative

This is the pay for this position
Pay Transparency
$194,000-$199,000 USD
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

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