Apogee Therapeutics is hiring a
Vice President

Summary

Join Apogee Therapeutics, a fast-paced biotechnology company, as Vice President of Formulations and Drug Product Development. Lead development and ensure robust drug product supply for launch/commercialization. Reporting to the SVP, Development, Manufacturing, & Supply.

Requirements

• PhD in relevant discipline (e.g., chemistry, biochemical engineering, or relevant field) or commensurate years of education and experience
• Minimum of 20 years of industry experience in formulations and drug product development and manufacturing
• Substantial experience leading drug product tech transfer to CDMOs and supporting DP campaigns with vials, syringes, and autoinjectors
• Proven success in late phase development and commercialization of biologics required
• Demonstrated ability to collaborate strategically and tactically with device, clinical development/operations, supply chain, analytical development, QA, and Regulatory
• Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Strategic thinker with the ability to drive decision-making and problem-solving in a fast-paced environment

Responsibilities

• Define and execute Apogee's drug product strategy across the portfolio
• Develop comprehensive strategies to advance clinical assets from Phase 1 through launch and commercialization
• Develop clinical and commercial formulations for recombinant proteins, including antibodies
• Conduct risk assessment and establish phase-appropriate product understanding and control strategies using QbD framework
• Support manufacture of clinical GMP DP throughout product lifecycle, including tech transfer, campaign analysis, and risk assessments
• Review and approve batch records, support investigations, and resolve deviations
• Collaborate effectively with cross-functional teams, including analytical development, device, supply chain, quality assurance, and regulatory affairs
• Analyze process and manufacturing data to understand and optimize process performance
• Author and support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.)
• Work closely with supply chain to support seamless clinical supply
• Liaise with device development to develop options and mitigate risks in transitioning between product configurations and novel delivery technology
• Guide the organization in optimizing business processes to support effective CMC management and communication
• Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team
• Author and review internal procedures, reports, and presentations

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