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CMC Project Manager

Cambridge, MA · On-site

A biopharmaceutical organization is looking to connect with experienced CMC Program Management ... Develop and maintain project plans, timelines, milestones, action items, and program trackers.

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How much do director cmc project management jobs pay per year?

As of Sep 10, 2026, the average yearly pay for director cmc project management in the United States is $124,379.00, according to ZipRecruiter salary data. Most workers in this role earn between $101,000.00 and $147,500.00 per year, depending on experience, location, and employer.

What is a director CMC project management?

A Director of CMC (Chemistry, Manufacturing, and Controls) Project Management oversees the development and execution of strategies related to the manufacturing and regulatory aspects of pharmaceutical products. They coordinate cross-functional teams to ensure that drug development, scale-up, and production processes meet regulatory requirements and project timelines. This role involves managing budgets, timelines, risk assessments, and communication between scientific, manufacturing, and regulatory departments. The Director also plays a key part in preparing documentation for regulatory submissions and ensuring compliance with global health authority standards.

How does a director CMC project management typically collaborate with cross-functional teams to ensure project success?

A Director of CMC Project Management works closely with teams across regulatory affairs, manufacturing, quality assurance, and research and development. They serve as the central point of contact, aligning project timelines, budgets, and deliverables while proactively identifying and mitigating risks. Regular cross-functional meetings, detailed project tracking, and transparent communication are key to ensuring all stakeholders are informed and aligned. This collaborative approach helps streamline processes, address challenges promptly, and keeps projects moving efficiently toward regulatory milestones.

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

To thrive as a Director CMC Project Management, you need deep expertise in chemistry, manufacturing, and controls (CMC), project leadership experience, and an advanced degree in a scientific discipline. Familiarity with regulatory requirements, quality management systems, and project management tools like MS Project or Smartsheet is typically required. Strong strategic thinking, cross-functional communication, and stakeholder management skills set standout leaders apart in this role. These capabilities are crucial for ensuring compliant, timely, and efficient development and manufacturing of pharmaceutical products.

What cities are hiring for Director Cmc Project Management jobs?

Cities with the most Director Cmc Project Management job openings:

What states have the most Director Cmc Project Management jobs?

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What are popular job titles related to Director Cmc Project Management jobs?

For Director Cmc Project Management jobs, the most frequently searched job titles are:

Associate Director, CMC Program Mgmt

South San Francisco, CA • On-site

Denali Therapeutics
Scientific Research and Development Services • 201 - 500 employees
Learn more about Denali Therapeuticsexternal

$159K - $207K/yr

Full-time

Medical, Retirement

Re-posted 12 hours ago

Job description

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
Denali Therapeutics is seeking to recruit a leader who will be responsible for organizing and managing CMC strategies, deliverables, and timelines for Denali's programs, including oversight of contract manufacturing organizations. As a member of the CMC Program Management group, this position is responsible for ensuring timely and optimal decision making across the CMC portfolio from the research phase through all phases of development, including approval (NDA, BLA, MAA) and commercial, working closely with our technical leaders, Program Directors, and cross-functional project teams to successfully integrate CMC deliverables into the overall project timelines.
Key Accountabilities/Core Job Responsibilities:
  • Organize, manage, and drive CMC strategies, plans, and deliverables for drug candidates from the research, pre-IND, and first-in-human testing phases to all later phases of development, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions
  • Manage CRO/CMO vendor selection process and serve as a point of contact for CROs and CMOs for outsourced CMC projects as well as early stage biotherapeutics requiring large scale material production
  • Facilitate, manage, and lead internal CMC project teams
  • Establish and maintain CMC project timelines and budgets and track CMC deliverables and timelines and ensure the CMC strategies and plans are incorporated into the overall project plans
  • Proactively outline risks and mitigations and communicate risks and issues to CMC teams, project teams, and senior management
  • Provide regular updates to senior management on project status, timelines, risks, and forecasting for future CMC project needs
  • Collaborate with technical leaders, Program Directors, and cross-functional project teams to develop and execute on drug development strategies and plans

Qualifications/Skills:
  • Typically requires a BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline, with 12+ years of relevant biotech/pharmaceutical/CMO CMC experience.(or Master's degree with 10+ years of experience)
  • An advanced degree and CMC Experience with novel constructs (e.g. bi-specifics, enzyme fusions) is preferred.
  • Experience managing CMC activities at CROs/CMOs required
  • Drug Substance and Drug Product GMP experience required
  • Command of project management practices and software
  • Thorough understanding of the overall drug development process
  • Excellent leadership, interpersonal skills and demonstrated ability to build effective working relationships and partnerships with internal team members and collaborators at CROs/CMOs
  • Experience in effectively working through high-pressure situations; excellent conflict management skills.
  • Drive to take ownership and responsibility in ensuring the success of the projects and deliverables. Results- and detail-oriented.

Salary Range: $159,000.00 to $207,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

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