Senior CMC Project Manager

Aurion Biotech is a clinical-stage biotechnology company dedicated to restoring vision to millions of patients through innovative regenerative therapies. The Senior CMC Project Manager will lead CDMO coordination and program integration for Aurion’s late-stage cell therapy program, managing external manufacturing partners and ensuring project timelines and deliverables are met.

Responsibilities:

• Drive strategic CDMO partnerships, serving as the primary day-to-day project manager and liaison to external partners ensuring alignment of project plans, timelines, and priorities
• Oversee CDMO performance and execution, monitoring progress against SOWs, timelines, and quality agreements, and coordinating timely resolution of deviations, delays, or scope changes
• Manage financial processes including PO creation, invoice review, and budget tracking to ensure on-time, on-budget delivery
• Lead internal and joint governance meetings, including scheduling, agenda preparation, and follow-up of decisions, risks, and actions. Consolidate CDMO and CMC program updates for dashboards and leadership reporting
• Build and maintain strong cross-functional relationships, fostering collaboration between Aurion, CDMO and internal SME’s ensuring clear communication and accountability across functions
• Own CMC project documentation and tools, maintaining integrated timelines, risk registers, decision logs, and action trackers, and ensuring Smartsheet and SharePoint systems are current and standardized
• Align cross-functional teams across Process Development, Manufacturing, Quality, Regulatory, and Supply Chain to ensure integrated planning, clear ownership, and consistent execution of program deliverables

Requirements:

• Bachelor's degree in a related field (e.g., Project Management, Engineering, Life Sciences)
• 8+ years of experience in Biotech/Pharma setting with 5+ years CMC or external manufacturing project management
• Strong organizational and time management skills, with the ability to prioritize tasks effectively
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
• Proficiency in Microsoft Office Suite, SharePoint, and Smartsheet
• Able to and comfortable with travel up to 25%
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met
• Must have strong attention to detail and demonstrated decision making ability
• Ability to work individually and in a team environment
• Demonstrated excellence in written and verbal communication skills
• Strong collaboration and demonstrated ability to work cross-functionally at all levels of the organization to drive strong business partner relationships
• Background in biotechnology or pharmaceutical development, with direct exposure to late-stage cell or gene therapy programs
• Knowledge of regulatory requirements related to pharmaceutical or biotechnology projects is preferred