Sr. CMC Project Manager

We are seeking a Sr. CMC Project Manager to join the Technical Operations Program & Strategy team at Apogee. This role is responsible for handling all CMC related documentation, managing the internal SharePoint site, migration of Tech Ops documents to Veeva Quality System, as well as provide Project Management support for one or more CMC Programs. This position requires a self-starter, who can organize projects effectively in a fast-paced setting. If you are interested in utilizing your CMC Project Management expertise to deliver innovative medicine to the patients, enjoy the fast-paced environment and thrive in a culture of growth and camaraderie, this role is for you. 

Key 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

Ideal Candidate

• 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)
• Experience with Process Characterization and PPQ is a plus
• 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
• Veeva experience is highly desired
• 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

The anticipated salary range for candidates for this role will be $160,000 - $175,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.