Sr. CMC Project Manager Job at Apogee Therapeutics

Job Description

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.

Job Responsibility

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
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

Nice to have

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

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

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Sr. CMC Project Manager

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