Sr. CMC Project Manager

Apogee Therapeutics is a clinical-stage biotechnology company focused on advancing novel biologics for significant unmet needs in the I&I markets. The Sr. CMC Project Manager will be responsible for managing CMC-related documentation, supporting CMC programs, and facilitating cross-functional collaboration to ensure project deliverables are met in a fast-paced environment.

Responsibilities:

• Lead the documentation flow between Tech Ops and our partners (CDMOs, external vendors) and maintain project documentation on SharePoint
• Maintain and communicate a current overview of Tech Ops documentation status and issues, including weekly dashboards to present to the upper management
• Responsible for migration of relevant Tech Ops documentation into the Veeva Quality System
• Work with various Tech Ops teams to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth
• Provide Project Management support for one or more CMC programs, including building and maintaining the CMC timelines by interfacing with our external partners and facilitating cross-functional collaboration with the Tech Ops
• Collaborate closely with the cross-functional Program Management team to ensure integration of Tech Ops activities into overall program plans, monitor project deliverables and ensure tasks are on track
• Responsible for purchase order initiation in NetSuite, review and approval of vendor accruals and invoices
• Responsible for tracking all outsourced activities

Requirements:

• Bachelor's degree in science
• 5+ years of experience in biotech or pharmaceutical industry with 3+ years of biologics development and manufacturing experience required
• 2+ years of Technical Operations/CMC experience
• Experience working with clinical stage candidates across all phases of Clinical Development (e.g., Ph 1 to Ph 3)
• Good technical knowledge of CMC development (Upstream, Downstream, Analytical), Supply Chain, CMC Regulatory Affairs, Quality, GMP requirements
• Extensive knowledge of Smartsheet and Microsoft Timeline a must
• Highly organized with meticulous attention to detail
• Ability to multi-task and keep pace with a fast-moving organization
• Ability to participate in calls across multiple international time zones
• Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient, and Egoless
• Position requires up to 20% travel including mandatory in-person attendance at All Hands meetings typically held twice per year. Will require travel to the Apogee lab in Boston, MA up to one week per year
• Experience with Process Characterization and PPQ is a plus
• Veeva experience is highly desired