Director, Formulation and Drug Product Development

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 VP of Formulation and Drug Product Development, this position requires deep expertise in process development, aseptic manufacturing for pre-filled syringes, device development, and compliance, while fostering collaboration across teams and external partners.  This person will act as a subject matter expert in pre-filled syringe drug product manufacturing within the CMC organization, providing strategic guidance and technical leadership across cross-functional teams.

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

Key Responsibilities 

• Act as the department’s subject matter expert in all aspects of pre-filled syringe process development and manufacturing, providing technical guidance and strategic insights to cross-functional teams
• Develop late-phase and commercial launch strategy for PFS development and manufacturing
• 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
• 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 qualification (PPQ), and commercial readiness
• Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies
• Analyze manufacturing data and identify opportunities for process improvement and optimization
• Support formulation and co-formulation development for protein therapeutics, including antibodies
• Support clinical studies through clinical dose preparation development and clinical in-use stability studies
• 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
• 5+ years of experience directing clinical and/or commercial Good Manufacturing Practice (GMP) operations for pre-filled syringe (PFS) drug products, ensuring regulatory compliance and operational excellence across all phases of manufacturing
• Demonstrated leadership in GMP manufacturing of combination products
• PhD in relevant discipline (e.g. chemical engineering, biochemical engineering, chemistry or related field) or commensurate years of education and experience
• Proven expertise in biologics drug product process development and aseptic manufacturing, preferably with a focus on monoclonal antibodies
• Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations
• Experience with process qualification (PPQ) and commercialization of biologics is highly preferred
• Demonstrated ability to collaborate with cross-functional stakeholders such as drug substance development, analytical development, supply chain, device development, clinical development, clinical operations, Quality, and Regulatory
• Excellent communication skills with ability to clearly and concisely convey information to various stakeholders and cross-functional teams
• Availability to participate in calls across international time zones
• Ability and willingness to travel up to 25%, including frequently to the Apogee lab in Boston

The anticipated salary range for candidates for this role will be $215,000 – $235,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

What We Offer

• 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
• Apogee offers regular all team, in-person meetings to build relationships and problem solve

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Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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