Senior CMC Project Manager

Project ManagerProject ManagerFull TimeRemoteTeam 51-200H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

67 days ago

Salary

$160K - $175K / year

Bachelor Degree5 yrs expEnglish

Job Description

• 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

Job 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