Director, Drug Product Development

Summary

Join Apogee Therapeutics as a Director of Drug Product Development to develop protein drug product presentations and processes, oversee tech transfer to and manufacturing at CDMOs, and deliver robust drug product supply for clinical trials and launch/commercialization.

Responsibilities

• Define and develop robust biologics drug product processes across the portfolio
• Oversee drug product manufacturing including tech transfer, process development, and GMP manufacturing operations including person in plant support
• Manage drug product CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members
• Support phase-appropriate strategies for drug product development, process transfer and scale-up as required, and late-phase commercial readiness
• Collaborate with drug product development and device teams to develop drug product presentations in vial, pre-filled syringe, and/or autoinjector
• Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies
• Trend manufacturing data and identify opportunities for process improvement and optimization
• Support formulation development and optimization for high concentration, injectability, compatibility, and shelf-life throughout product development lifecycle
• Collaborate to develop and optimize biologics co-formulations and drug product presentations
• Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations
• Communicate findings and progress through presentations and reports
• Support authoring of regulatory submissions (IND, IMPD, BLA, briefing books, etc.)