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Cmc Program Manager Jobs in California (NOW HIRING)

GeneFab

Advanced Therapies CMC Program Manager

Alameda, CA · On-site

$175K - $200K/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 ...

GeneFab

Advanced Therapies CMC Program Manager

Alameda, CA · On-site

$175K - $200K/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 ...

Gilead

Manager, Regulatory Affairs CMC

Foster City, CA · On-site

$146K - $189K/yr

The CMC Regulatory Affairs Manager is responsible forsupporting the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs. This role ...

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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 California look for? The top searched job categories for Cmc Program Manager jobs in California are:
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Cmc Program Manager jobs near you
Infographic showing various Cmc Program Manager job openings in California as of June 2026, with employment types broken down into 3% As Needed, 90% Full Time, and 7% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution.

Advanced Therapies CMC Program Manager

GeneFab

Alameda, CA

$175K - $200K/yr

Full-time

Re-posted 5 days ago

Job description

We are seeking a Program Manager to drive cell and gene therapy Contract Research, Development, and Manufacturing Organization (CRDMO) programs within an Integrated Project Delivery (IPD) framework. This role supports the full product development lifecycle - from biological design and process development through pivotal manufacturing and regulatory submission - operating as a shared-accountability leader embedded within a unified, cross-functional project team. The ideal candidate brings deep technical expertise, a collaborative leadership style, and the agility to co-own outcomes with sponsors, internal partners, and external parties under IPD principles of transparency, early risk surfacing, and joint decision-making.

Key Responsibilities: IPD Program Leadership & Governance
  • Lead the workstream within the Integrated Project Team (IPT), co-owning program outcomes with Synthetic Biology, Process Development, Analytical Development, MSAT, Quality Control, GMP Manufacturing, Regulatory Affairs, Finance and sponsor partners.
  • Facilitate IPT working sessions and Joint Steering Committee (JSC) meetings; frame decisions with full context, scenario analysis, and downstream impact.
  • Champion IPD principles: shared risk/reward, open-book collaboration, and joint decision-making across all workstreams.
  • Drive escalation to governance committees at the right level and time; iterate on PMO frameworks, risk registers, and project review boards to improve oversight.
Key Responsibilities: Project Execution (Customer oriented and internal R&D)
  • Lead end-to-end program execution, including therapeutic design, process and analytical development, pivotal readiness, method qualification/validation, pilot & engineering run strategies, and regulatory submission readiness.
  • Drive cross-functional alignment across SynBio, PD, AD, MSAT, QC, and GMP Manufacturing to ensure process consistency, data integrity, and regulatory compliance.
  • Translate technical data into program decisions with clear traceability to TPPs, CQAs, CPPs, and regulatory expectations.
  • Orchestrate knowledge transfer at key project stages, including onboarding new intellectual property, technology transfer from PD to GMP Manufacturing, and handoffs between customers and internal teams and third party partners in real time.
  • Co-lead CMC regulatory strategy with Regulatory Affairs; own the CMC content roadmap and ensure data packages are submission-ready for IND, IMPD, BLA/MAA, or applicable filings.
  • Serve as primary point of contact for sponsors and clients; lead integration sessions that bring sponsor teams into the delivery process as active IPD participants.
  • Manage scope, deliverables, and expectations, lead change order and scope modification discussions in collaboration with Business Development and technical leads.
  • Track program budgets, resource forecasts, and milestone-based invoicing using IPD cost-transparency practices for real-time financial visibility.
  • Identify, quantify, and manage technical, regulatory, and timeline risks; develop scenario-based mitigation strategies and advocate for resources (personnel, equipment, capacity) as needed.

 

Qualifications
  • Bachelor's degree (required) in Life Sciences, Bioengineering, Chemical Engineering, or related field; advanced degree (MBA/M.S./Ph.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 submissions.
  • Demonstrated experience leading programs in an IPD, alliance management, or co-development model; CRDMO/sponsor partnership experience strongly preferred.
  • Track record leading cross-functional product development projects (SynBio, PD, AD, MSAT, MFG, QC,)
  • PMP certification, IPD, Lean, or Alliance Management training a plus.
  • Proficiency with Smartsheet Advance, ThinkCell, and integrated scheduling platforms; strong quantitative, risk modeling, and KPI design skills.
  • Proven ability to lead without direct authority in a matrixed, shared-accountability environment; excellent communication, facilitation, and negotiation skills.
  • High adaptability and emotional intelligence; comfortable with fast-paced, distributed, cross-functional settings.
$175,000 - $200,000 a year
About GeneFab 
GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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