Senior Program Manager, CMC

2 weeks ago

Alameda County, United States Enigma Search Full time

On behalf of our client, a leader in cell and gene therapy development, we are seeking a Senior CMC Program Manager to oversee and drive complex programs across the Chemistry, Manufacturing, and Controls (CMC) lifecycle. This role is pivotal in ensuring the successful progression of cutting-edge therapies, coordinating cross-functional teams and managing client relationships from early development through GMP manufacturing and regulatory submissions.

This strategic and business-critical position requires expertise in tech transfer, CMC strategy, and project management, with the ability to deliver measurable results while navigating technical and regulatory complexities.


Key Responsibilities:


CMC Program Management

  • Lead full lifecycle CMC programs, from planning to execution and delivery of milestones, such as GMP readiness and regulatory submissions.
  • Coordinate cross-functional efforts across Process Development (PD), Analytical Development (AD), Manufacturing Sciences and Technology (MSAT), Quality Control (QC), and Manufacturing (MFG).
  • Act as the primary client liaison, defining scopes, timelines, KPIs, and pathways for issue resolution.

Tech Transfer and Development

  • Oversee tech transfers, ensuring readiness across development and manufacturing functions.
  • Manage workflows to transition projects seamlessly from development to GMP manufacturing.
  • Ensure process and assay development meet scalability and quality standards.

Governance and Risk Management

  • Develop and refine project governance frameworks and PMO best practices.
  • Lead Joint Steering Committee (JSC) meetings, ensuring alignment on key decisions.
  • Identify and mitigate risks, leveraging scenario planning and structured frameworks.


Client and Stakeholder Management

  • Build and maintain strong client relationships, managing expectations and deliverables.
  • Partner with technical and business development teams on change orders and scope adjustments.


Strategic Advocacy and Resource Management

  • Advocate for additional resources and operational capacity as needed to meet program demands.
  • Monitor budgets, track resource allocation, and ensure alignment with project milestones.



Qualifications:


Education

  • Bachelor’s degree in Life Sciences, Engineering, or a related field.


Experience

  • 3–5+ years of project or program management experience in biotech, pharma, or cell and gene therapy.
  • Proven experience managing CMC lifecycle projects involving PD, AD, MSAT, MFG, and QC.
  • Familiarity with regulatory submissions (IND, IMPD, BLA) and compliance.
  • Experience working with sponsor drug development or CDMOs preferred.
  • PMP certification strongly preferred.


Skills

  • Deep understanding of CMC operations and workflows within GMP environments.
  • Exceptional problem-solving and strategic thinking abilities.
  • Strong communication, negotiation, and client management skills.
  • Ability to manage budgets, advocate for resources, and align cross-functional teams.
  • Proficiency with project management tools like Smartsheet and ThinkCell.

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