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Cmc Jobs (NOW HIRING)

Altimmune

CMC Director, Regulatory Affairs

Gaithersburg, MD · Remote

$153K - $202K/yr

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 ...

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 ...

Altimmune

CMC Director, Regulatory Affairs

Gaithersburg, MD

$162K - $213K/yr

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 ...

Vaxcyte

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 global regulatory requirements are considered and incorporated into product development. Conducts routine ...

Lancesoft

CMC Technical Writer

Ridgefield, CT · On-site

$54 - $55.70/hr

We are seeking an experienced Analytical Subject Matter Expert (SME) and CMC Technical Writer to support external drug substance (DS) and drug product (DP) development programs within External ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site

$180K - $210K/yr

Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine ...

Allucent

Sr. Director, CMC

Cary, NC · On-site +1

As a Sr. Director, CMC at Allucent, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or ...

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Cmc information

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$13

$31

$67

How much do cmc jobs pay per hour?

As of Jun 22, 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 are the key skills and qualifications needed to thrive as a CMC (Chemistry, Manufacturing, and Controls) 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 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 CMC professionals?

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 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 June 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, and 2% Contract. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $64,986 per year, or $31.2 per hour.
Director, CMC Project Management

Director, CMC Project Management

Sionna Therapeutics Inc

Waltham, MA • On-site

$210K - $230K/yr

Full-time

Posted 23 days ago

Job description

Description:

Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide-binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. Leveraging over a decade of the co-founders’ extensive research on NBD1, the company is advancing a pipeline of novel small molecules engineered to correct the defects caused by the F508del genetic mutation, which resides in NBD1. Sionna is also developing a portfolio of complementary CFTR modulators that are designed to work synergistically with its NBD1 stabilizers to improve CFTR function.

Position Summary:

Sionna Therapeutics is seeking a Director, CMC Project Management who will be responsible for facilitating and coordinating the strategic planning, integration, and execution of the company’s CMC development programs across the portfolio. This position serves as a vital role within CMC, driving cross-functional alignment, integrated planning, and execution from pre-clinical development through commercial readiness.


Reporting to the Senior Vice President of CMC, this individual will partner closely with CMC, Clinical Drug Supply, Regulatory, Quality Assurance, Finance, and Program Leadership to ensure CMC programs are aligned with corporate goals and clinical development plans.


Responsibilities:

Program Management

  • Drive the creation and ongoing management of integrated program plans, including timelines, priorities, milestones, risk registers, and action plans.
  • Manage a portfolio of CMC projects, ensuring alignment with corporate goals and clinical development plans.
  • Support the development of clear, data-driven scenarios and strategic options that enable agility and well-informed decision-making.
  • Facilitate effective cross-functional team coordination, meeting management, and execution against deliverables.
  • Ensure consistent application of project management best practices, including project plans, dashboards, timelines, risk registers, and governance.
  • Identify, establish, and continuously improve project management processes, tools, metrics, and operating models across CMC teams to improve efficiency.

Operational Excellence

  • Ensure CMC project meetings and CMC governance meetings are agenda-driven and focused on efficient decision-making.
  • Coordinate and document agenda and meeting notes for meetings with internal and external stakeholders to ensure clear communication and expectations as well as efficient execution of CMC activities and CMC governance meetings.

Financial Management

  • Manage the CMC project budgets to ensure accurate forecasting, alignment with strategic priorities and accountability across CMC.
  • Facilitate the review and approval of CDMO scopes of work, purchase orders, and invoices.
Requirements:
  • Bachelor’s degree (advanced degree preferred) in Chemistry, Pharmaceutics, or related field.
  • 12+ years of experience in pharmaceutical or biotech industry, with at least 3 years of experience in CMC project management or related technical operations role or equivalent experience.
  • Experience with small molecule and solid oral dosage form development preferred.
  • PMP or PMI certification is beneficial but not required.
  • Experience collaborating with CDMO partners.
  • Demonstrated analytical, problem-solving, and scenario planning skills.
  • Exceptional organizational and communication skills and a demonstrated ability to work independently and collaboratively across all levels of the organization.
  • Curious, adaptable, and energizing leader adept at leading through change.
  • Champions and models the organization’s values, fostering a culture of quality, inclusion, and continuous improvement across all teams.
  • Proficiency with project management tools such as Smartsheet or OnePager preferred.
  • Ability to thrive in a fast-paced, dynamic environment with shifting priorities.

Salary Range: $210,000 – $230,000

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