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Cmc Program Manager Jobs in New York (NOW HIRING)

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · Hybrid

Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to ... Strong project management and organizational skills. * Ability to manage multiple programs and ...

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · On-site

Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to ... Strong project management and organizational skills. * Ability to manage multiple programs and ...

// Praxis //

Manager, Quality Operations, CMC

Manhattan, NY · On-site +1

$117K - $137K/yr

Represent Product Quality on CMC, program, and external partner teams, providing strategic Quality ... management. Hands‐on experience with batch disposition, deviations and investigations, change ...

// Praxis //

Manager, Quality Operations, CMC

Manhattan, NY · On-site +1

$117K - $137K/yr

Represent Product Quality on CMC, program, and external partner teams, providing strategic Quality ... management. Hands‐on experience with batch disposition, deviations and investigations, change ...

Pathos

Director, CMC - Biologics & ADC

New York, NY · On-site

$210K - $250K/yr

There is no middle management. There are no layers of approval. The company is designed, from the ... Serve as the CMC program lead and single point of accountability, representing CMC on cross ...

Pathos

Director, CMC - Biologics & ADC

Manhattan, NY · On-site

$210 - $250/hr

There is no middle management. There are no layers of approval. The company is designed, from the ... Serve as the CMC program lead and single point of accountability, representing CMC on cross ...

Pathos AI

Director, CMC - Biologics & ADC

Manhattan, NY · On-site

$210 - $250/hr

There is no middle management. There are no layers of approval. The company is designed, from the ... Serve as the CMC program lead and single point of accountability, representing CMC on cross ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

... Management on pertinent regulatory intelligence * Represents and participates in project/program ... Experience in CMC regulatory lifecycle management, including compiling, reviewing, and managing CMC ...

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Cmc Program Manager information

What is a CMC Program Manager?

CMC Program Managers are professionals responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of pharmaceutical or biotechnology product development. They coordinate cross-functional teams to ensure that drug development activities related to product formulation, manufacturing, quality, and regulatory submissions are completed on time and within budget. Their role is crucial in advancing products through clinical development to commercialization while ensuring compliance with global regulatory requirements.

What are the key skills and qualifications needed to thrive as a CMC Program Manager?

To thrive as a CMC Program Manager, you need expertise in chemistry, manufacturing, and controls (CMC), project management experience, and an advanced degree in life sciences or a related field. Familiarity with regulatory submission systems, quality management tools, and certifications such as PMP or Six Sigma are highly valued. Strong leadership, cross-functional communication, and problem-solving skills help manage diverse teams and complex projects effectively. These skills ensure the successful development, regulatory compliance, and timely delivery of pharmaceutical products.

What are some typical challenges a CMC Program Manager faces when coordinating cross-functional teams?

A CMC Program Manager often encounters challenges in aligning the goals and timelines of diverse teams such as process development, analytical, regulatory, and manufacturing. Communication gaps and shifting priorities can complicate project execution, especially when managing external partners or contract manufacturing organizations. Proactive stakeholder engagement and clear documentation are essential to ensure that everyone remains on track and regulatory requirements are met. Successfully navigating these complexities is key to advancing products efficiently through the development pipeline.

What is the difference between Cmc Program Manager vs Cmc Project Manager?

AspectCmc Program ManagerCmc Project Manager
CredentialsTypically requires a Bachelor's degree in life sciences, engineering, or related field; often certifications like PMP or PgMPUsually holds a Bachelor's degree in a relevant field; PMP certification is common
Work EnvironmentOversees multiple projects within a program, coordinating cross-project activities in biotech or pharma industriesManages individual projects, focusing on specific deliverables within the CMC scope
Employer & IndustryPharmaceutical, biotech, or life sciences companies managing complex product developmentSimilar industry, often within the same companies, focusing on specific project execution

The Cmc Program Manager oversees multiple related projects, ensuring alignment with strategic goals, while the Cmc Project Manager focuses on executing individual projects within the CMC domain. Both roles require similar credentials and work in the same industry, but differ in scope and responsibilities.

What are popular job titles related to Cmc Program Manager jobs in New York?

For Cmc Program Manager jobs in New York, the most frequently searched job titles are:

What job categories do people searching Cmc Program Manager jobs in New York look for?

The top searched job categories for Cmc Program Manager jobs in New York are:

What cities in New York are hiring for Cmc Program Manager jobs?

Cities in New York with the most Cmc Program Manager job openings:

Cmc Program Manager jobs near you
Infographic showing various Cmc Program Manager job openings in New York as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 18% Part Time, and 4% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution.

Manager, Regulatory CMC

Somerset, NJ • Hybrid

Legend Biotech US
See more jobs at Legend Biotech USexternal

Full-time

Posted 6 days ago

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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