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Cmc Program Manager Jobs in New York (NOW HIRING)

Recursion

Director, CMC Regulatory Affairs

New York, NY · On-site

$207K - $255K/yr

Influence the regulatory strategy of Recursion's development programs by attending team meetings ... Strategize , plan, write, manage internal and external contributors and review region specific ...

ZS

Decision Analytics Consultant- CMC

Manhattan, NY · On-site

$160K - $177K/yr

As a management consulting and technology firm focused on improving life and how we live it, we ... Milestone training programs aligned to career progression opportunities * Internal mobility paths ...

Neion Bio

Head of Biologics

New York, NY · On-site

$170K - $230K/yr

... CMC programs through regulatory interactions. This person will initially manage a small team of downstream process development and analytical scientists and will play a central role in building Neion ...

Neion Bio

Head of Biologics

Manhattan, NY · On-site

$170K - $230K/yr

... CMC programs through regulatory interactions. This person will initially manage a small team of downstream process development and analytical scientists and will play a central role in building Neion ...

Neion Bio

Head of Biologics

Manhattan, NY · On-site

$170K - $230K/yr

... CMC programs through regulatory interactions. This person will initially manage a small team of downstream process development and analytical scientists and will play a central role in building Neion ...

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All JobsCmc Program JobsCmc Program Manager JobsCmc Program Manager Jobs in New York

Cmc Program Manager information

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 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 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:
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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, 17% Part Time, 1% Temporary, and 4% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Director - CMC Regulatory Affairs (Gene Therapy)

Stark Pharma Solutions Inc

Piscataway, NJ • Remote

$153K - $202K/yr

Contractor

Re-posted 7 days ago

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Director – CMC Regulatory Affairs position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Role: Director – CMC Regulatory Affairs (Gene Therapy)

Location: Remote (Anywhere in the U.S.)
 

We're looking for an experienced Director – CMC Regulatory Affairs to join a well-funded, mid-sized Gene Therapy Biotech organization with a strong pipeline and proven success.

Key Responsibilities

  • Lead CMC Regulatory Affairs strategy for gene therapy programs.
  • Author and review CMC sections for regulatory submissions (INDs, BLAs, amendments, and global filings).
  • Collaborate with CMC, Manufacturing, Quality, and Regulatory teams to ensure compliant submissions.
  • Support interactions with regulatory agencies and drive submission readiness.
  • Provide strategic regulatory guidance throughout product development and commercialization.

Required Qualifications

  • Extensive experience in CMC Regulatory Affairs within the biotechnology or pharmaceutical industry.
  • Hands-on experience authoring CMC regulatory content (not just reviewing submissions).
  • Strong knowledge of FDA and global regulatory requirements for biologics/gene therapy products.
  • Experience supporting INDs, BLAs, and other regulatory submissions.
  • Excellent communication, leadership, and cross-functional collaboration skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com