Director, Formulation and Drug Product Development

 

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

Role Summary

We are seeking a Director, Formulation and 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. Reporting to the Vice President, Formulation and Drug Product Development, this role requires significant expertise in protein drug product development including formulation development, process development, aseptic manufacturing including pre-filled syringes, support of clinical studies, quality and regulatory compliance, and ability to collaborate with cross-functional teams and external partners.

Embedded in the Formulation and Drug Product Development team, this position will be a member of an integrated Development, Manufacturing & Supply team, and will work closely with team members involved in drug substance development, device development, analytical development, and supply chain. 

Key Responsibilities 

• Support drug product and formulation development strategies to advance clinical assets from Phase 1 through launch and commercialization
• Define and develop robust biologics drug product manufacturing processes across the portfolio
• Collaborate with drug product development and device teams to develop drug product presentations in vial, pre-filled syringe, autoinjector, and advanced delivery technologies.
• Develop formulations and co-formulations for protein therapeutics, including antibodies
• Support clinical studies through clinical dose preparation development, design and oversight of clinical in-use stability studies, and collaborate with cross-functional teams to prepare clinical study documentation such as Pharmacy Manuals and Investigator Brochures
• Oversee drug product 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, process characterization, process validation, and commercial readiness
• Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies
• Analyze and trend stability data to evaluate formulations and product shelf-life
• Analyze manufacturing data and identify opportunities for process improvement and optimization
• Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations
• Author and review regulatory submissions (IND, IMPD, BLA, briefing books, etc.)

Ideal Candidate 

• Minimum of 12 years industry experience in drug product development and manufacturing
• PhD in relevant discipline (eg, chemical engineering, biochemical engineering, chemistry or related field) or commensurate years of education and experience
• Significant experience with formulation development of recombinant proteins, including antibodies
• Significant experience in biologics drug product process development and aseptic manufacturing
• Experience with prefilled syringe dosage forms and combination products
• Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations
• Track record of advancing assets from pre-clinical through IND and into late phase de