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Cmc Biotech Jobs (NOW HIRING)

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.

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 13, 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.

Manager, Regulatory CMC

Somerset, NJ • Hybrid

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

Full-time

Posted 22 days ago

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 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 regulatory strategies for pipeline programs, with a strong focus on regulatory dossier authoring and cross-functional collaboration to advance product development milestones.

Key Responsibilities

  • Support the development and execution of global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and lentiviral vector products.
  • Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to plan, prepare, review, and coordinate CMC components of global regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments, supplements, and responses to Health Authority requests.
  • Author, review, and maintain high-quality CMC regulatory documentation to support global development, registration, and commercialization activities, ensuring compliance with applicable regulatory requirements and company standards.
  • Collaborate with cross-functional technical teams, including Process Development, Manufacturing,
  • Analytical Development, and Quality, to understand complex CMC information and effectively translate it into clear, scientifically sound regulatory submissions.
  • Evaluate and interpret technical documentation, including development reports, validation protocols and reports, comparability assessments, and manufacturing change packages, to support regulatory impact assessments, submission strategies, and regulatory decision-making.

Requirements

  • Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biochemistry, Chemistry, Engineering, or related discipline required. Advanced degree (MS, PhD, PharmD) preferred.
  • 5+ years of biotechnology or pharmaceutical industry experience with strong technical background.
  • Minimum of 1-2 years of Regulatory CMC experience supporting biologics, cell and gene therapy products, or extensive experience authoring and managing CMC sections of regulatory dossiers and submissions.
  • Experience working with process development, analytical development, or manufacturing teams.
  • Experience supporting cell and gene therapies highly preferred.
  • Familiarity with global regulatory requirements, including FDA, EMA, and ICH guidelines.
  • Strong scientific understanding and technical background on biologics or cell and gene therapy products.
  • Excellent technical writing and document preparation skills with demonstrated experience authoring regulatory submission content.
  • Ability to critically review and interpret scientific and technical data and translate complex information into clear regulatory documentation.
  • Strong project management and organizational skills.
  • Ability to manage multiple programs and competing priorities in a fast-paced environment.
  • Strong communication and collaboration skills with cross-functional stakeholders.

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