Senior CMC Program Manager (Contract)

Senior Program Manager

Location: Alameda, CA

Reports To: Associate Director, Program Management

About the Role:

We are seeking a strategic and business-minded Senior CMC Program Manager to lead and oversee complex cell and gene therapy programs across the full Chemistry, Manufacturing, and Controls (CMC) lifecycle. This individual will collaborate closely with external clients and internal cross-functional teams to ensure high-quality delivery of project milestones, from early process development through GMP manufacturing and regulatory submissions.

The ideal candidate will serve as a central figure in coordinating stakeholders across Process Development (PD), Analytical Development (AD), Manufacturing Sciences and Technology (MSAT), Quality Control (QC), and Manufacturing (MFG). This role requires strong expertise in tech transfer, CMC strategy, and project management to drive successful execution of critical program milestones, such as tox lot production, regulatory readiness, and commercial scalability. With experience in tech transfers, project management, and business strategy, this individual will ensure that projects are delivered on time, within budget, and with measurable impact.

Key Responsibilities:

• CMC Program Management

• Lead the end-to-end management of CMC programs, including planning, execution, and delivery of critical milestones (e.g., tox lot production, GMP manufacturing readiness, regulatory submissions).

• Drive cross-functional coordination between PD, AD, MSAT, MFG, QC, and QA teams, ensuring all CMC activities align with program goals.

• Serve as the primary point of contact for clients, establishing clear project scopes, timelines, KPIs, and escalation pathways to ensure alignment and success.

• Tech Transfer and Development

• Oversee seamless tech transfers from early-stage development to GMP manufacturing, ensuring readiness across PD, AD, MSAT, and QC functions.

• Ensure process development and assay development meet internal and client expectations for quality and scalability.

• Manage internal handoffs between Tech Dev, MSAT, MFG, and QC to ensure efficient workflows and successful milestone delivery.

• Governance and Escalation

• Prepare for and potentially run Joint Steering Committee (JSC) meetings, ensuring that decisions are framed with appropriate context, deadlines, and impact analysis.

• Define and improve PMO frameworks, including project review boards and governance structures, to support cross-functional integration and improve oversight.

• Develop best practices for project and risk management to improve team efficiency and governance across projects.

• Lead escalation processes to governance committees for key decisions, ensuring alignment between senior stakeholders.

• Identify root causes of challenges, develop actionable solutions, and present options using tools such as scenario planning (if this, then that) and frameworks like input-process-output.

• Client and Stakeholder Management

• Develop and maintain strong client relationships, acting as a trusted partner to manage scope, deliverables, and expectations.

• Lead discussions on change orders, pricing, and scope modifications in collaboration with technical teams and Business Development (BD).

• Strategic Resource Advocacy

• Advocate for additional resources, such as personnel, equipment, or operational capacity, based on project needs and priorities.

• Proactively identify risks, resource constraints, and mitigation strategies to ensure program success.

• Financial and Risk Management:

• Track project budgets, forecast resource needs, and ensure financial alignment with milestone-based invoicing.

• Identify and manage risks, including technical, regulatory, and timeline delays, and propose actionable mitigation strategies.

Qualifications:

• Education:

• Bachelors degree in Life Sciences, Engineering, or a related field.

• Experience:

• 3-5+ years of project or program management experience in biotech, pharmaceuticals, or cell and gene therapy, with experience across the CMC lifecycle.

• Expertise in managing cross-functional projects involving PD, AD, MSAT, MFG, and QC, with a strong understanding of GMP environments.

• Experience with sponsor drug development and/or working with CDMOs is a plus.

• Demonstrated ability to support IND, IMPD, or BLA submissions and regulatory compliance activities.

• Project Management Professional (PMP) certification strongly preferred

• Skills:

• Comprehensive understanding of CMC operations, including PD, AD, MSAT, and GMP MFG workflows.

• Strong strategic thinking and problem-solving abilities, with expertise in scenario planning and project frameworks like input-process-output.

• Excellent communication and negotiation skills, with the ability to align stakeholders and manage client relationships effectively.

• Demonstrated ability to advocate for resources and manage project budgets.

• Comfortable working in a fast-paced environment with shifting priorities and external dependencies.

• Proficiency with project management tools, such as Smartsheet Advance and ThinkCell.

What We Offer:

• Opportunity to work on cutting-edge CMC programs in the growing field of cell and gene therapy.

• A collaborative work environment where your ideas and contributions directly shape program success.

• Professional development opportunities with room for growth and advancement.