Job Details

We are seeking a Senior CMC Program Manager with expertise in GMP-centric programs to lead and oversee pivotal and late-stage cell and gene therapy programs. This role will focus on driving pivotal readiness, process optimization, method qualification/validation, and risk mitigation strategies for cell and gene therapy products.

The ideal candidate will have deep experience managing GMP CMC operations, including process development to GMP manufacturing, regulatory submissions, and commercial scalability. This role requires strong expertise in tech transfer, CMC strategy, and risk-based decision-making to ensure the successful execution of critical milestones such as pivotal manufacturing, yield improvements, process validation, and regulatory readiness. With experience in GMP CMC, project management, and business strategy, this individual will ensure that projects are delivered on time, within budget, and with measurable impact.

Key Responsibilities: GMP CMC Program Management

• Lead the end-to-end execution of GMP programs, focusing on pivotal readiness, method qualification/validation, and risk-based decision-making for the delivery of critical milestones (e.g. Pilot & Engineering run strategies, GMP manufacturing readiness, regulatory submissions).
• Drive cross-functional alignment between Process Development (PD), Analytical Development (AD), Manufacturing Sciences and Technology (MSAT), Quality Control (QC), and GMP Manufacturing (MFG) to ensure process consistency and regulatory compliance.
• Serve as the primary point of contact for clients, establishing clear project scopes, timelines, KPIs, and escalation pathways to ensure alignment and success.

• Oversee seamless tech transfers from PD to GMP MFG, ensuring readiness across upstream, downstream, and analytical 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.

• Prepare for and potentially run Joint Steering Committee (JSC) meetings, ensuring that decisions are framed with appropriate context, deadlines, and impact analysis.
• Work within and improve PMO frameworks, including project review boards and governance structures, to support cross-functional integration and improve oversight.
• Iterate on best practices for project and risk management to improve team efficiency and governance across projects.
• Drive 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.

• 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).

• 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.

• 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.

• Minimum of a bachelor's degree in Life Sciences, Engineering, or a related field.

• 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
• Experience with CAR-T and CAR-NK products strongly preferred

• 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.

• 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.