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Cmc Biotech Jobs (NOW HIRING)

Legend Biotech US

Director, Regulatory CMC

Somerset, NJ · Hybrid

$158K - $209K/yr

Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. Key Responsibilities * Develop, lead, and execute global CMC regulatory strategies ...

New

Legend Biotech US

Director, Regulatory CMC

Somerset, NJ · On-site

$193K - $254K/yr

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Develop, lead, and execute global CMC regulatory strategies across commercial products and ...

New

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · Hybrid

Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. Role Overview This position will support the development and execution of global CMC ...

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · On-site

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in ...

Legend Biotech USA, Inc.

$193K - $254K/yr

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based ...

New

Legend Biotech USA, Inc.

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in ...

Korsana Biosciences, Inc.

VP, CMC

Waltham, MA · On-site

$300K - $340K/yr

The position requires strategic vision and hands-on experience managing early-stage biotech programs in a dynamic, fast-paced environment. Responsibilities * Develop, implement, and execute CMC ...

Korsana Biosciences, Inc.

VP, CMC

Waltham, MA · On-site

$300K - $340K/yr

The position requires strategic vision and hands-on experience managing early-stage biotech programs in a dynamic, fast-paced environment. Responsibilities * Develop, implement, and execute CMC ...

Korsana Biosciences

VP, CMC

Waltham, MA · On-site

$300K - $340K/yr

The position requires strategic vision and hands-on experience managing early-stage biotech programs in a dynamic, fast-paced environment. Responsibilities * Develop, implement, and execute CMC ...

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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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Cmc Biotech jobs near you
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.

Director, Regulatory CMC

Somerset, NJ • Hybrid

Legend Biotech US
Biotechnology Research and Development • 1 - 5K employees
Learn more about Legend Biotech USexternal

$158K - $209K/yr

Full-time

Posted 2 days ago

New

Legend Biotech rating

9.2

Company rating: 9.2 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

Job description

Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ.

Key Responsibilities

  • Develop, lead, and execute global CMC regulatory strategies across commercial products and development- stage programs, with primary accountability for late-stage development and post-approval lifecycle management activities.
  • Provide strategic regulatory leadership to cross-functional teams, influencing development and manufacturing strategies, identifying regulatory risks and opportunities, and driving effective mitigation and contingency plans to support program objectives.
  • Serve as the primary Regulatory CMC representative on cross-functional program teams and governance committees, ensuring alignment of regulatory strategies with corporate and portfolio goals.
  • Lead and coordinate regulatory CMC planning, preparation of submissions, and interaction with Health Authorities.
  • Establish and maintain strong partnerships with internal stakeholders and external collaborators to ensure effective execution of regulatory objectives.
  • Drive continuous improvement initiatives within the Regulatory CMC function, including development of regulatory processes, best practices, and knowledge management to enhance organizational effectiveness and compliance.
  • Guide and support junior staff as applicable.

Requirements

  • Advanced degree in life sciences, biotechnology, pharmaceutical sciences, engineering, or related discipline.
  • 10+ years of biotechnology or pharmaceutical industry experience.
  • 7+ years of Regulatory CMC experience supporting biologics, cell and gene therapy. Direct experience with CAR-T cell therapies is desired.
  • Strong CMC technical background is required. Ability to critically evaluate data from a broad range of scientific disciplines.
  • Demonstrated experience leading late-stage programs and post-approval Regulatory CMC experience supporting commercial products, including lifecycle management, supplements, variations, annual reports, and post-approval commitments.
  • Demonstrated global CMC regulatory experience.
  • Deep understanding of global CMC requirements on cell and gene therapy.
  • Expertise in late-stage development and lifecycle management.
  • Strong leadership, strategic thinking, communication, and technical writing skills.
  • Ability to manage multiple programs.

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