Senior Associate / Manager, CMC Operations

Role Summary

Senior Associate / Manager, CMC Operations supports CMC financial and operational activities across Relay Tx’s development programs. In a cross-functional role, you will partner with internal technical leads and external manufacturing partners to ensure timely, compliant, and efficient delivery of clinical materials and associated documentation by providing support to the Pharmaceutical Development Team. The ideal candidate has strong project management and operational execution skills with experience in a clinical-stage biotech environment, capable of navigating complex, cross-functional deliverables.

Responsibilities

• Collaborate with CMC, Accounting, and Finance teams to support the creation and maintenance of department budgets and forecasts.
• Generate and finalize all departmental Purchase Orders (POs) within the Coupa system; track progress to ensure timely approval.
• Confirm that all PO requests are accurately captured in the budget; escalate and obtain approval for any items not previously included.
• Ensure contracts contain appropriate legal language, milestones, and payment terms.
• Track CMC operational expenses against budget by conducting monthly reviews of accruals in partnership with CMC functional leads (Drug Substance, Drug Product, Analytical Development, Quality, and Clinical Supply) and Finance.

• Support the onboarding of new CMC and supply chain vendors.
• Meet with vendors monthly (or as needed) to monitor spending against approved contracts.
• Coordinate internal and external vendor communications and action items, including contract and PO management, budget and accrual oversight, material transfers, and inventory system support.

• Support the execution of CMC activities across Drug Substance, Drug Product, Analytical Development/Manufacturing, and Clinical Supply Chain, including scheduling and project management tasks.
• Assist in the development and alignment of CMC project plans, risk assessments, and timelines with overall program goals; ensure timely communication of project status, timeline changes, cost updates, and risks to team members and functional leaders.
• Facilitate internal CMC team meetings, track action items, and maintain documentation to drive operational excellence.
• Contribute to continuous improvement efforts across CMC processes, tools, and data management systems.

Education

• Bachelor‚Äôs degree in life sciences, engineering, business, or a related field required.

Experience

• 3 to 5 years of experience in CMC operations, technical operations, or pharmaceutical manufacturing within a biotech or pharmaceutical company.
• Experience supporting clinical-stage programs and working with CDMOs.
• Working knowledge of GMP, ICH guidelines, and regulatory expectations for CMC development.

Skills

• Strong project management, organizational, and communication skills.
• Detail-oriented and proactive, with the ability to anticipate and resolve issues.
• Collaborative mindset with the ability to work effectively within cross-functional teams.
• Comfortable operating in a dynamic environment with evolving priorities.