Senior CMC Project Manager
Apogee Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Salary
💰 $160,000 - $175,000 per year
Job Level
About the role
- 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)
- 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
Benefits
- A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
- Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Project ManagementTechnical OperationsCMCProcess CharacterizationPPQGMPSupply ChainQualityBiologics DevelopmentClinical Development
Soft skills
Highly organizedAttention to detailMulti-taskingCross-functional collaborationCommunicationProblem-solvingTime managementAdaptabilityInterpersonal skillsLeadership