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Cmc Program Manager Jobs in Maryland (NOW HIRING)

Pharmaron

Quality Control Data Reviewer I

Germantown, MD · On-site

$68K - $75K/yr

... 100+ CMC programs , and 1,397 clinical trials across all phases. Our teams are involved in ... Review sample management documentation and verify samples are appropriately documented and stored ...

Axle Informatics

Registered Nurse

Rockville, MD · On-site

With experts in biomedical science, software engineering, and program management, we focus on ... Report should be sent to the NIAID CMC Contracts Team and the Task Leader every month and include:

Axle

Registered Nurse

Rockville, MD · On-site

With experts in biomedical science, software engineering, and program management, we focus on ... Report should be sent to the NIAID CMC Contracts Team and the Task Leader every month and include:

Pharmaron

Clinical Informatics Specialist

Baltimore, MD · On-site

$24 - $30/hr

... 100+ CMC programs , and 1,397 clinical trials across all phases. Our teams are involved in ... Works in collaboration with the Project Manager to ensure database build timelines are met. What We ...

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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 Maryland?

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

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

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

What cities in Maryland are hiring for Cmc Program Manager jobs?

Cities in Maryland with the most Cmc Program Manager job openings:

Cmc Program Manager jobs near you
Infographic showing various Cmc Program Manager job openings in Maryland as of June 2026, with employment types broken down into 1% As Needed, 79% Full Time, 18% Part Time, 1% Temporary, and 1% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Senior Process Engineer, Global Manufacturing Science and Technology, Cell Therapy Technical Op[...]

Socket.dev

Gaithersburg, MD • On-site

$96.20 - $144.29/hr

Other

Medical, Dental, Vision, Retirement, PTO

Posted 9 days ago

Job description

ResponsibilitiesDevelopment and Manufacturing Interface
  • Represent Global MSAT in the technology transfer and process characterization teams to ensure successful commercialization of cell therapy products.
  • Communicate Manufacturing Operations needs to the CMC team, ensuring high-quality and timely program deliverables (comparability and validation study completion, etc).
  • Develop PPQ readiness and PPQ execution technical framework for the site MSAT team and oversee execution at the manufacturing sites.
  • Implement proactive process analysis and Continued Process Verification (CPV) strategies across manufacturing sites to ensure continued process understanding and control across all sites.
Lifecycle Management
  • Provide technical oversight across cell therapy manufacturing lifecycle — from pivotal manufacturing technology transfer, process validation, commercialization, and post‑approval.
  • Identify and implement process improvements that increase robustness, cost of goods, plant throughput, and supply continuity.
  • Contribute to post‑approval process optimization initiatives, comparability strategies, ensuring scientific rigor and managing regulatory risks.
  • Proactively identify and mitigate technical and operational risks; ensure standardization across sites and teams.
Regulatory & Quality Support
  • Lead global Change Controls and ensure timely implementation and compliance.
  • Contribute to authoring CMC sections of regulatory submissions — Pivotal INDa, BLA, MAA, and supplements — with high efficiency and optimal content.
  • Partner with quality and regulatory to maintain full compliance with cGMP, ICH guidelines, and global regulatory expectations.
  • Develop and defend sound scientific justifications for the integrated control strategy and lifecycle changes.
Cross‑Functional Partnerships
  • Late‑Stage Process Development – provide MSAT input for process definition, improvements, and process characterization.
  • Site MS&T – partner to ensure timely implementation of process changes and improvements at the sites.
  • Quality – ensure process compliance and product quality standards.
  • Supply Chain – inform long‑range supply planning and risk mitigation.
Qualifications
  • Education: B.S. or M.S. or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline. Advanced degree preferred.
  • Experience: Ph.D. with 1+ years; OR M.S. with 5+ years, OR B.S. with 7+ years of relevant cell therapy/biologics/vaccines industry experience in technical development, MS&T, or CMO management areas.
  • Technical and hands‑on expertise in cell therapy manufacturing processes and technologies is highly desirable. Experience in viral vectors, vaccines, or biologics will be considered.
  • Background in GMP manufacturing operations and technology transfer.
  • Experience in process validation and CPV desired.
  • Experience in authoring CMC sections for major regulatory filings (INDa, BLA, MAA) and regulatory inspections.
  • High standards of quality, accountability, and urgency — with the resilience to thrive in a fast‑paced cell & gene therapy field.
Benefits

The annual base pay for this position ranges from $96,196.80 - $144,295.20. Our positions offer eligibility for various incentives—an opportunity to receive short‑term incentive bonuses, equity‑based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Equal Employment Opportunity

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.

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