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Cmc Biotech Jobs (NOW HIRING)

Director, CMC Management

San Carlos, CA · On-site

$200K - $250K/yr

Cross functional experience leading or coordinating CMC development in a biotech or pharmaceutical company * Experience in managing CMC transitions from development to commercial manufacturing and ...

New

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable ... Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or ...

Ph.D. in biotechnology, biotechnology engineering, biochemistry or cell and molecular biology from an accredited institution strongly preferred, with at least 5-7 years of relevant industry ...

New

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Cmc Biotech information

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How much do cmc biotech jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for cmc biotech in the United States is $28.94, according to ZipRecruiter salary data. Most workers in this role earn between $21.39 and $33.41 per hour, depending on experience, location, and employer.

What is a CMC Biotech professional?

CMC Biotech professionals specialize in Chemistry, Manufacturing, and Controls (CMC) within the biotechnology industry. They are responsible for developing, manufacturing, and ensuring the quality and regulatory compliance of biopharmaceutical products from early development through commercialization. Their work includes process development, scale-up, analytical testing, and creating documentation for regulatory submissions. CMC experts play a crucial role in bringing safe and effective biotech therapies to market.

What are the key skills and qualifications needed to thrive as a CMC Biotech professional?

To thrive as a CMC Biotech professional, you need a strong background in biochemistry, molecular biology, regulatory affairs, and process development, often supported by an advanced degree in life sciences or chemical engineering. Familiarity with regulatory submission tools (such as eCTD), quality management systems, and analytical instrumentation is critical. Strong project management, attention to detail, and cross-functional communication skills help ensure effective collaboration and compliance. These competencies are essential for developing safe, effective biotech products while meeting stringent regulatory standards.

What are some common challenges faced by CMC Biotech professionals when working cross-functionally with other departments?

CMC (Chemistry, Manufacturing, and Controls) Biotech professionals often collaborate closely with teams in research, quality assurance, regulatory affairs, and production. A common challenge is aligning timelines and expectations across departments, as regulatory requirements and quality standards may evolve during product development. Effective communication and proactive project management are crucial to ensure that all teams are aligned, especially when handling complex data or responding to regulatory feedback. Building strong cross-functional relationships and maintaining flexibility can help CMC professionals successfully navigate these challenges.
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What states have the most Cmc Biotech jobs?

States with the most job openings for Cmc Biotech jobs include:

Infographic showing various Cmc Biotech job openings in the United States as of September 2026, with employment types broken down into 4% As Needed, 89% Full Time, 2% Part Time, and 5% Contract. Highlights an 78% Physical, 4% Hybrid, and 18% Remote job distribution, with an average salary of $60,196 per year, or $28.9 per hour.

Associate Director, CMC Program Mgmt

South San Francisco, CA

Denali Therapeutics
Scientific Research and Development Services • 201 - 500 employees

$159K - $207K/yr

Full-time

Medical, Retirement

Re-posted 2 days 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.