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Apogee Therapeutics · 4 days ago

Sr. CMC Project Manager

United States

Full-time

Hybrid

Senior Level

$160K/yr - $175K/yr

5+ years exp

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of various inflammatory and immunology conditions. They are looking for a Sr. CMC Project Manager to handle CMC related documentation, manage internal systems, and provide project management support for CMC programs.

BiotechnologyLife ScienceMedicalTherapeutics

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

Qualification

CMC Project ManagementBiologics DevelopmentTechnical Operations/CMCVeeva Quality SystemSmartsheetGMP RequirementsMulti-taskingCaringOriginalResilientEgolessAttention to DetailCross-functional Collaboration

Required

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

Preferred

Experience with Process Characterization and PPQ is a plus

Veeva experience is highly desired

Benefits

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits

We provide competitive time off, including 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