Remote Associate Director, CMC Operations and Project Management

Summary

Join Apogee Therapeutics as an Associate Director, CMC Operations and Project Management to handle external DS or DP CDMO relationships, provide project management support for CMC programs, and utilize your expertise in a fast-paced environment.

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 PhIII to Commercial, such as DS or DP Process Characterization and PPQ is a must
• Good technical knowledge of DS/DP Process development, Analytical, Regulatory, 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

Responsibilities

• Manage all operational and project management aspects of the external DS or DP 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

Benefits

• 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