Senior Program Manager, CMC (Contract)

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.