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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 are CMC Program Managers?

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, and why are they important?

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.
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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:
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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.
Associate Director, External Operations, Cell Therapy - External Supply Management

Associate Director, External Operations, Cell Therapy - External Supply Management

AstraZeneca

Gaithersburg, MD • On-site

$115K - $173K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 2 days ago

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

19th of 86 rated pharmaceutical

Job description

The Associate Director, External Operations, Cell Therapy - External Supply Management, leads external manufacturing partner operations. These operations span a network of CDMOs and external partners supporting cell therapy across autologous, allogeneic, in vivo, and new platforms. You will create operational governance, tech transfer, batch execution, investigations, and risk management to meet supply, quality, and cost targets. You will support programs across development, clinical, scale-up, validations, launch readiness and commercialization as portfolio evolves. You will partner cross-functionally with CMC Product Leadership, Process Development, Quality, Regulatory, Procurement, and Finance to ensure external supply.
The role is based in Gaithersburg, MD and report to the Head of External Supply - Cell Therapy Products
You will:
  • Lead daily operational management of assigned CDMOs/external manufacturing partners to ensure performance against supply, quality, and cost targets.
  • Guide execution across tech transfer, manufacturing, release, delivery, issue resolution, deviations, investigations.

  • Be a primary operational interface across technical operations, Quality, Supply Chain, Regulatory, CMC, Program management, finance, procurement and legal
  • Lead change management implementation at external partners following CMC Product Strategy. Oversee/coordinate change control, impact assessment, and implementation plan.
  • Establish and run partner governance, including business reviews, escalation pathways, performance monitoring and action tracking
  • Translate program needs and demand plans into executable external supply plans and clear partner priorities
  • Build, accountable relationships with external partners while on execution, quality, timeline, cost and supply reliability
  • Support negotiations and content of contracts such as MSAs, SOWs, Change Orders and other commercial agreements to ensure they reflect operational scope, supply requirements, governance, milestones and cost of goods optimization. . Manage supplier's performance against the contract deliverables.
  • Oversee budget input to Program Budgets and monitor spend against budgets.
  • Promote continuous improvements of external operations processes, scorecards and way of working across the network
  • Ensure end-to-end integration of physical and financial flows in SAP across CDMO operations covering master data, subcontracting, batch status/release, GR/IR, variance and WIP settlement, and KPI reporting.

You have:
  • Bachelor's degree in engineering, life sciences or related discipline is required; advanced degree preferred.
  • Minimum 8+ years' experience in biotech, pharma or advanced therapy GMP operations.
  • Experience applying lean, structural and continuous improvement to deliver more efficient and reliable operations.
  • Cross-functional leadership, communication, and stakeholder management.
  • Experience working in and with multiple geographies and achieve success through collaboration.
  • Experience applying digital, analytics and AI-enabled workflows to improve visibility, workflow efficiency and operational execution.

Desired skills:
  • Experience in SAP and inventory to COGS.
  • At least 2 years of experience in cell and gene therapy including management of CDMOs and external suppliers.

The annual base pay for this position ranges from $115K to $173K. Our positions offer eligibility for multiple 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.
Date Posted
14-Jul-2026
Closing Date
30-Jul-2026
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. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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