Associate Director, CMC Operations and Project Management

Summary

Join Apogee Therapeutics as an Associate Director, Technical Operations Project Management and manage all project management aspects of external Drug Substance CDMO relationships for one of our CMC Programs. You will work with the Tech Ops team, collaborate with cross-functional teams, and ensure projects stay on track. This role requires a Bachelor's degree in science, 8+ years of biotech/pharmaceutical experience, and 5+ years of Technical Operations/Project Management experience. The ideal candidate possesses strong technical knowledge, expertise in project management software, and the ability to work effectively in a fast-paced environment. Apogee offers a competitive compensation and benefits package, including flexible PTO, company-wide shutdowns, and professional development opportunities. The anticipated salary range is $165,000-$190,000/year.

Requirements

• Bachelor’s degree in science
• 8+ years of experience in biotech or pharmaceutical industry with 3-5 years of Biologics development and manufacturing experience
• 5+ years of Technical Operations/ Project Management experience
• Experience working with clinical stage candidates across all phases of Clinical Development (e.g., PhI to PhIII)
• Good technical knowledge of DS, Process development, Analytical, Regulatory, Quality, GMP requirements
• High level of expertise of Smartsheet, Microsoft Project, One Pager, and Office Timeline
• Assertive and proactive
• 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
• Ability and willingness to travel (up to 15%) to company All Hands Meetings, and the Apogee lab in Boston. Some international travel may be required

Responsibilities

• Manage all operational and project management aspects of the external DS CDMO relationship
• Work with Tech Ops team members to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth
• Provide Project Management support for 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
• Submit purchase orders in NetSuite, review and approve vendor revenue recognition, accruals, and invoices
• Assist with tracking outsourced activities for other Tech Ops groups as needed

Preferred Qualifications

Experience with Late Stage (Process Characterization and PPQ) is a plus

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• 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
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• 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