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Cmc Program Manager Jobs in California (NOW HIRING)

Reporting to the VP, Pharma Program Management), this position requires collaboration across ... Develop and lead all GMP CMC-related activities (biologics and small molecule) including process ...

Clinical Services Nurse

Vista, CA · On-site

$33.50 - $45/hr

If applicable, the CM will coordinate care for Cal Medi-Connect program members to ensure all aspects of the CMC program description are implemented and followed. A case manager is a licensed LVN. A ...

Clinical Services Nurse

Vista, CA · On-site

$33.50 - $45/hr

If applicable, the CM will coordinate care for Cal Medi-Connect program members to ensure all aspects of the CMC program description are implemented and followed. A case manager is a licensed LVN. A ...

Director of CMC

El Segundo, CA · On-site

$200K - $230K/yr

Reporting to the VP, Pharma Program Management), this position requires collaboration across ... Develop and lead all GMP CMC-related activities (biologics and small molecule) including process ...

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Cmc Program Manager information

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.

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 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 California? For Cmc Program Manager jobs in California, the most frequently searched job titles are:
What job categories do people searching Cmc Program Manager jobs in California look for? The top searched job categories for Cmc Program Manager jobs in California are:
What cities in California are hiring for Cmc Program Manager jobs? Cities in California with the most Cmc Program Manager job openings:
Infographic showing various Cmc Program Manager job openings in California as of May 2026, with employment types broken down into 51% Full Time, 46% Part Time, and 3% Contract. Highlights an 90% Physical, and 10% Remote job distribution.

$200K - $230K/yr

Other

Posted 19 days ago


Job description

About this Role

Our pharmaceutical team is looking for a highly motivated and creative Director of Chemistry, Manufacturing and Control (CMC) to lead expansion and growth of partner pharma activities toward clinical production. This role will be responsible for all CMC activities across the external drug development pipeline of Varda's partners. Reporting to the VP, Pharma Program Management), this position requires collaboration across multiple departments and external partners to design, develop, and implement novel approaches to manufacture drug products in low Earth orbit. This is an opportunity in an exciting area of growth for Varda, the role will shape Varda's product culture and will play a significant role in establishing the low Earth orbit economy. The ideal candidate must create and lead the CMC development team for drug products from early stage through clinical manufacturing.

Responsibilities
  • Develop and lead all GMP CMC-related activities (biologics and small molecule) including process chemistry, drug product, analytical, and formulation from lead optimization phase through to clinical development and commercialization  
  • Build and lead internal GMP CMC team with functions around process development, quality control, and quality assurance. 
  • Manage external drug product manufacturing service providers and API supply chains to support clinical trial development  
  • Collaborate with Varda pharma R&D teams to understand future CMC needs and handle internal tech transfers 
  • Author all CMC sections of regulatory filings including FDA, EMA and other national authorities to support the conduct of clinical trials 
  • Act as subject matter expert for non-clinical CMC to both preclinical and clinical development teams, interact with all internal and external stakeholders to support CMC needs 
  • Ensure high-quality standards, develop SOPs, implement GMP compliance and QC/QA 
  • Monitor progress and regularly report to the C-suite team 
  • Manage and monitor the CMC timelines and budget 
Basic Qualifications
  • 8+ years of CMC leadership experience advancing drug product development programs to successful clinical trials 
  • B.S. or M.S. in life sciences such as Chemistry, Biochemistry, or related fields 
  • Firm understanding of cGMP and FDA regulatory guidelines as they pertain to CMC 
Preferred Skills and Experience
  • 12+ years of CMC leadership experience advancing drug product development programs to successful clinical trials 
  • PhD in life sciences such as Chemistry, Biochemistry, or related fields 
  • Documented evidence of prior successful CMC project leadership from early phase, late phase leading to clinical trials. 
  • Experience in leading and direct management of research, analytical laboratories, process development, and manufacturing 
  • Advanced understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas 
  • Command of global CMC-related regulatory requirements and guidelines 
  • Excellent leadership, managerial and communications skills in a cross functional environment 
  • Hands-on experience in managing multiple internal and external stakeholders (e.g. working with CMOs on managing drug product development) 
  • Experience with writing CMC sections for regulatory filings and knowledge of current regulations in US and EU 
  • Fluent communication in English, written and verbal 
Pay Range
  • Salary range: $200,000 - $230,000/per year
  • This role is on-site in El Segundo, CA
  • Leveling and base salary is determined by job-related skills, education level, experience level, and job performance
  • You will be eligible for incentives in the form of stock options and/or long-term cash awards