Apogee Therapeutics is hiring a
Associate Director

Summary

Join Apogee Therapeutics as an Associate Director, CMC Project Management to handle all aspects of the external CDMO relationship and provide project management support for our other CMC Programs. This role requires a self-starter who can organize projects effectively in a fast-paced setting.

Requirements

• Bachelor’s degree in science
• 10+ years of experience in biotech or pharmaceutical industry with 5-8 years of Biologics development and manufacturing experience
• 5+ years of Technical Operations/CMC Project Management experience
• Experience working with clinical stage candidates across all phases of Clinical Development (e.g., PhI to PhIII). Experience with Late Stage (Process Characterization and PPQ) is a plus
• Good technical knowledge of CMC development, CMC Regulatory Affairs, Quality, GMP requirements and device
• High level of expertise of Smartsheet, Microsoft Project, OnePager, 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

Responsibilities

• Manage all operational and project management aspects of the external 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 one of our 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
• Create efficiencies for processes and streamline operational activities
• Review and approve vendor accruals and invoices
• Assist with tracking outsourced activities as needed

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
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development