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Cmc Director Jobs (NOW HIRING)

Critical Innovations

Director of CMC

Lawndale, CA · Hybrid

Overview The Director of CMC is responsible for day-to-day leadership and execution of Critical Innovations' Chemistry, Manufacturing, and Controls (CMC) activities, with primary oversight over ...

Varda Space Industries

Director of CMC

El Segundo, CA

$200K - $230K/yr

About this Role Our pharmaceutical team is looking for a highly motivated and creative Director of Chemistry, Manufacturing and Control (CMC) to lead expansion and growth of partner pharma activities ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA · On-site

$161.80K - $213.60K/yr

The Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages of ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA

$161.80K - $213.60K/yr

The Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages of ...

Varda Space Industries

Director of CMC

El Segundo, CA · On-site

$200K - $230K/yr

About this Role Our pharmaceutical team is looking for a highly motivated and creative Director of Chemistry, Manufacturing and Control (CMC) to lead expansion and growth of partner pharma activities ...

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 ...

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$43.5K

$127.5K

$239K

How much do cmc director jobs pay per year?

As of May 29, 2026, the average yearly pay for cmc director in the United States is $127,543.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,000.00 and $150,500.00 per year, depending on experience, location, and employer.

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

To thrive as a CMC (Chemistry, Manufacturing, and Controls) Director, you need deep expertise in pharmaceutical development, regulatory requirements, and quality assurance, typically supported by an advanced degree in chemistry, pharmacy, or a related field. Familiarity with regulatory submission systems (e.g., eCTD), quality management systems (QMS), and relevant certifications such as PMP or Six Sigma is often required. Strong leadership, project management, and cross-functional communication skills set successful CMC Directors apart. These competencies ensure the efficient development and compliance of pharmaceutical products from concept through commercialization, meeting regulatory standards and business goals.

What are the main challenges a CMC Director faces when coordinating between regulatory, manufacturing, and R&D teams?

A CMC Director often navigates complex challenges in aligning the priorities and timelines of regulatory, manufacturing, and R&D teams. Balancing the need for regulatory compliance with the fast-paced demands of product development requires strong communication and project management skills. Additionally, adapting to evolving global regulatory standards while ensuring manufacturing processes remain efficient and scalable is a key part of the role. Close collaboration and proactive problem-solving are essential to ensure products move smoothly from development to commercialization.

What are CMC Directors?

CMC Directors, or Chemistry, Manufacturing, and Controls Directors, are senior professionals responsible for overseeing the development, production, and quality assurance of pharmaceutical products. They manage the CMC aspects of drug development, ensuring that products meet regulatory requirements and quality standards from research through commercialization. CMC Directors lead cross-functional teams, coordinate with regulatory agencies, and play a crucial role in ensuring that manufacturing processes are efficient, compliant, and scalable. Their expertise helps bring safe and effective medications to market while adhering to regulatory timelines and budgets.

What is the difference between Cmc Director vs Cmc Manager?

AspectCmc DirectorCmc Manager
ResponsibilitiesOversees entire CMC development, strategic planning, and regulatory complianceManages daily operations, coordinates teams, and executes CMC activities
Required CredentialsAdvanced degree (PhD, MSc), extensive industry experience, regulatory knowledgeBachelor's or Master's degree, relevant industry experience
Work EnvironmentStrategic, leadership-focused, often in corporate officesOperational, team management, hands-on in labs or manufacturing

The Cmc Director typically holds a higher strategic role, focusing on overall development and compliance, while the Cmc Manager handles daily operations and team coordination. Both roles require relevant industry experience, but the director's responsibilities are broader and more strategic.

More about Cmc Director jobs
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Cmc Director jobs near you
Infographic showing various Cmc Director job openings in the United States as of May 2026, with employment types broken down into 4% Full Time, 81% Part Time, 6% Temporary, 8% Contract, and 1% Summer. Highlights an 95% Physical, and 5% Remote job distribution, with an average salary of $127,543 per year, or $61.3 per hour.
CMC Director/Senior Director, Regulatory Affairs

CMC Director/Senior Director, Regulatory Affairs

Altimmune

Gaithersburg, MD • On-site

$162.10K - $213.90K/yr

Full-time

Posted 11 days ago

Job description

Altimmune (NASDAQ: ALT) is a clinical stage biopharmaceutical company focused on developing treatments for obesity and liver diseases. Our pipeline includes next generation peptide therapeutics for treatment of obesity, metabolic dysfunction-associated steatohepatitis (MASH), alcohol-associated liver disease (ALD), and alcohol use disorder (AUD). For more information, please visit .
Job Description: This individual will be responsible for providing global regulatory CMC support throughout the product lifecycle (e.g., regulatory strategies, preparing CMC filings and submissions to regulatory applications, regulatory submission timeline development, and regulatory intelligence). This position reports to the Head of Regulatory Affairs.
Essential Functions:
  • Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial applications
  • Manages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goals
  • Responsible for the preparation of all CMC sections/information filed in support of global clinical trial and marketing applications; ensures all CMC regulatory filings are prepared accurately and completed in a timely manner
  • Manages global CMC regulatory projects as assigned and assists in the development of relevant timelines and ensures execution to meet corporate goals
  • Performs regulatory assessments of CMC changes, identifying global regulatory filing requirements
  • Responsible for submission of supporting amendments and updates to relevant applications for CMC-related changes
  • Manages the preparation and submission of formal CMC-related regulatory meeting requests and briefing packages and coordinates meetings with regulatory agencies
  • Leads CMC-related FDA meetings and interfaces with regulatory/competent authorities, negotiating resolution of regulatory issues affecting Altimmune's development programs
  • Interprets FDA regulations/guidelines governing drugs, devices, and biologics and advises Senior Management on pertinent regulatory intelligence
  • Represents and participates in project/program teams and sub-teams, as required
  • Participates in the development, review, and implementation of departmental SOPs and processes.

Job Requirements (Essential knowledge, skills and attributes):
  • S/Ph.D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma industry
  • Experience in CMC regulatory lifecycle management, including compiling, reviewing, and managing CMC modules of eCTD submissions
  • Operational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agencies
  • Ability to interpret FDA Regulations, EU Directives, and global regulatory guidelines governing CMC filing requirements for approval of marketing and clinical trial applications for drugs and biological products
  • Excellent planning, organization, and project management skills, including the ability to adjust to rapidly changing priorities and manage multiple projects simultaneously
  • Experience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs)
  • Must be self-motivated with a positive attitude and ability to work well with others
  • Excellent oral and written communication skills.

Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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