ZipRecruiter

Log In

1

Cmc Program Manager Jobs in Washington, DC (NOW HIRING)

Rivet

Housing Management Expert

Arlington, VA · On-site

Analyze housing program performance, financial sustainability, occupancy trends, utilization data ... CMC) testimony and executive briefing materials. Support housing privatization initiatives ...

previous pagenext page

Showing results 21-40

All JobsCmc Program JobsCmc Program Manager JobsCmc Program Manager Jobs in Washington, DC

Cmc Program Manager information

See Washington, DC salary details

$43.6K

$121.7K

$177.8K

How much do cmc program manager jobs pay per year?

As of Aug 23, 2026, the average yearly pay for cmc program manager in Washington, DC is $121,709.00, according to ZipRecruiter salary data. Most workers in this role earn between $90,000.00 and $150,100.00 per year, depending on experience, location, and employer.

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 Washington, DC?

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

What job categories do people searching Cmc Program Manager jobs in Washington, DC look for?

The top searched job categories for Cmc Program Manager jobs in Washington, DC are:

Cmc Program Manager jobs near you

Senior Small Molecule Regulatory Affairs & Compliance Subject Matter Expert

Tunnell Government Services

Bethesda, MD • Remote

Full-time

Posted 26 days ago

Job description

Senior Small Molecule Regulatory Affairs & Compliance Subject Matter Expert

Location: Remote (U.S.-based) with approximately 20-25% travel

The Senior Small Molecule Regulatory Affairs & Compliance SME will provide strategic regulatory expertise, program management support, and technical guidance for the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) initiative and related pharmaceutical manufacturing programs. This initiative seeks to establish a resilient domestic ecosystem for the development, approval, manufacturing, stockpiling, and deployment of critical small-molecule generic medicines and their active pharmaceutical ingredients (APIs).

The selected individual will serve as the Federal Government's regulatory expert for FDA-regulated small-molecule drug products, providing oversight and guidance regarding regulatory strategy, ANDA/NDA submissions, CMC development, manufacturing compliance, approval pathways, and lifecycle management activities.

Position Overview

This position serves as a senior regulatory affairs and compliance SME supporting programs involving:

  • Small molecule APIs and finished dosage forms
  • Generic drug development and approval
  • Strategic API stockpiling initiatives
  • Domestic manufacturing expansion and reshoring efforts
  • Manufacturing technology modernization
  • Supply chain resiliency and emergency preparedness programs
  • FDA regulatory engagement and product approval activities

The candidate will work closely with Government leadership, pharmaceutical manufacturers, CDMOs, regulatory agencies, quality organizations, and technical teams to ensure products and manufacturing operations meet regulatory requirements and support program objectives.

Key Responsibilities

  • Serve as Regulatory Subject Matter Expert (SME) for small-molecule generic drug development, manufacturing, and approval programs.
  • Provide scientific, technical, and regulatory guidance for assigned programs and projects.
  • Review and assess contractor and partner regulatory strategies, timelines, and submission plans.
  • Support and evaluate FDA interactions
  • Assess regulatory risks and recommend mitigation strategies to support successful approvals and compliance objectives.
  • Monitor evolving FDA regulations, guidance documents, and industry expectations relevant to generic pharmaceuticals.
  • Review and provide guidance on FDA submissions.
  • Support development of data-driven submission strategies that facilitate efficient FDA review and approval.
  • Evaluate submission readiness and regulatory documentation supporting approvals of critical generic medicines.
  • Assess Chemistry, Manufacturing, and Controls (CMC) strategies for API and drug product programs.
  • Review manufacturing development plans, technology transfer strategies, validation programs, and commercial manufacturing readiness.
  • Conduct regulatory research, intelligence gathering, and competitive landscape assessments.
  • Monitor trends in generic drug approvals, manufacturing regulations, and supply chain resiliency initiatives.
  • Serve as the regulatory representative on multidisciplinary teams supporting strategic pharmaceutical manufacturing initiatives.

Required Qualifications

  • Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, Biology, Regulatory Affairs, or a related scientific discipline.
  • Advanced degree (M.S., Pharm.D., MBA, J.D., Ph.D., or equivalent) strongly preferred.
  • 15+ years of pharmaceutical industry experience supporting small-molecule drug development, manufacturing, regulatory affairs, quality, or compliance functions.
  • Experience supporting and implementing regulatory emergency response mechanisms, including Emergency Use Authorization (EUA), expiration dating extensions, and enforcement discretion strategies.
  • Experience with FDA Emerging Technology Program (ETP) engagements and Advanced Manufacturing Technology (AMT) initiatives, including the evaluation, implementation, and regulatory support of innovative manufacturing processes and platforms.
  • Demonstrated experience leading or supporting successful FDA submissions and approvals, including:
    • ANDAs
    • DMFs
    • NDA supplements
    • Post-approval changes
  • Extensive experience interacting directly with FDA and supporting regulatory meetings and inspections.
  • Strong knowledge of:
    • FDA drug approval pathways
    • Generic drug regulations
    • CDER review processes
    • cGMP requirements
    • CMC regulatory requirements
    • Drug Master Files
    • Quality Systems
  • Experience supporting manufacturing operations, technology transfer, validation, and commercial production activities.
  • Ability to assess complex regulatory, manufacturing, and compliance issues and develop practical solutions.
  • Strong written and verbal communication skills.

Must be a US Citizen or a Full Green Card holder.

Apply