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Cmc Program Manager Jobs in California (NOW HIRING)

About the Role >>> Program Manager, CMC As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical ...

CMC Program Management * Manage CMC timelines, milestones, deliverables, and cross-functional coordination. * Track and communicate progress on analytical development, stability studies, and CMC ...

D.) is nice to have. * 5-8+ years of CMC program management experience in biotech, pharma, or cell and gene therapy across the full CMC lifecycle. Experience supporting IP, IND, BLA, MAA, or IMPD ...

CRDMO Program Lead

Alameda, CA · On-site

$175K - $215K/yr

D.) is nice to have. * 5-8+ years of CMC program management experience in biotech, pharma, or cell and gene therapy across the full CMC lifecycle. Experience supporting IP, IND, BLA, MAA, or IMPD ...

CRDMO Program Lead

Alameda, CA · On-site

$175K - $215K/yr

D.) is nice to have. * 5-8+ years of CMC program management experience in biotech, pharma, or cell and gene therapy across the full CMC lifecycle. Experience supporting IP, IND, BLA, MAA, or IMPD ...

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 ...

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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.
Program Manager, CMC

Program Manager, CMC

Olema Oncology

San Francisco, CA

Other

Posted 11 days ago


Job description

About the Role >>> Program Manager, CMC 

As the Program Manager, CMC reporting to the Director, CMC Program Management, you will lead integrated CMC program planning and execution across clinical development stages. You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with Technical Operations (CMC technical leads), Quality, Regulatory, Supply Chain, Finance and external partners. You will serve as an operational leader - driving accountability, facilitating alignment, managing risk, and helping teams navigate challenges effectively.   

This role can be based out of our San Francisco, CA or Boston, MA offices and will require 10% travel

Your work will primarily encompass:

  • Lead integrated CMC planning across Drug Substance (DS), Drug Product (DP), Analytical (AC), Quality (QA), Regulatory (RA), and Supply Chain (SC), partnering with Director- and Senior Director-level functional leaders to define deliverables, timelines, and priorities aligned to clinical and regulatory goals. 
  • Build and maintain integrated project timelines in Smartsheet (or similar tools), ensuring dependencies, critical path activities, and milestones are clearly defined and tracked. 
  • Identify program risks, drive mitigation planning with functional leads, and escalate issues as needed to maintain timelines. 
  • Facilitate CMC sub-team meetings, document decisions and action items, and ensure follow-through across internal teams and external partners. 
  • Prepare leadership-ready status updates and presentations, track key program metrics, and maintain clear documentation of plans, risks, and decisions. 
  • Support regulatory submission readiness by aligning CMC deliverables, documentation, and cross-functional inputs to filing timelines. 
  • Partner with Technical Operations and CDMOs to drive coordinated execution and proactively identify risks to supply or compliance. 
  • Strengthen CMC program management practices, tools, and planning processes to support scalable, efficient execution. 
  • Provide program-level budget visibility and tracking in collaboration with functional leads and Finance. 
  • Contribute to a collaborative, accountable, and team-oriented culture within CMC and across Olema. 

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledgeexperience, and attributes for this role. 

Knowledge: 

  • Bachelor's degree required, Life Sciences or related disciplines preferred. 
  • Proficiency in Microsoft Office Suite (PowerPoint, Excel, Outlook), Smartsheet (or equivalent PM tools), and collaboration platforms (e.g., MS Teams, SharePoint). 
  • Knowledge of CMC development processes across clinical stages. 
  • Familiarity with regulatory submission timelines and CMC documentation requirements preferred. 

Experience: 

  • Minimum 5+ years of experience in life sciences program management and/or drug development operations with a bachelor's degree, or 3+ years with a master's degree. 
  • Experience driving CMC execution in early clinical-stage development (Phase 1-2), with exposure to Phase 3 readiness considered a plus. 
  • Working cross-functionally within drug development teams (Drug Substance, Drug Product, Analytical, Quality, Regulatory Affairs, Supply chain). 
  • Demonstrated experience building and managing integrated project plans, identifying critical path activities, and proactively managing risks and dependencies. 
  • Collaborating and interacting with external vendors/CDMOs. 
  • Experience preparing materials for team or leadership meetings. 

Attributes: 

  • Highly organized with strong attention to detail and follow-through. 
  • Energetic, proactive, and action-oriented - a true "go-getter." 
  • Friendly and approachable with a collaborative mindset. 
  • Strong communicator who can tailor messaging to diverse audiences. 
  • Skilled at bridging functions and building strong working relationships. 
  • Comfortable navigating a fast-paced, evolving environment. 
  • Solutions-oriented with sound judgment and appropriate escalation. 
  • Strong team player who thrives in highly collaborative settings. 

The base pay range for this position is expected to be $150,000-$170,00 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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