Senior Director, Formulation and Drug Product Development

Summary

Join Apogee Therapeutics, a Nasdaq-listed biotechnology company, as their Senior Director, Formulation and Drug Product Development. You will play a key role in developing protein drug product presentations and processes, overseeing tech transfer to CDMOs, and ensuring robust drug product supply for clinical trials and commercialization. This position requires significant expertise in protein drug product development, including formulation development, process development, and aseptic manufacturing. You will collaborate extensively with cross-functional teams and external partners. The role reports to the Vice President, Formulation and Drug Product Development and offers a competitive salary and benefits package.

Requirements

• Minimum of 15 years industry experience in drug product development and manufacturing
• PhD in relevant discipline (eg, chemical engineering, biochemical engineering, chemistry or related field)
• 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 development
• Extensive experience with cGMPs and knowledge of regulatory guidance
• 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

Responsibilities

• Develop drug product and formulation development strategies to advance clinical assets from Phase 1 through launch and commercialization
• Develop clinical and commercial formulations and co-formulations for protein therapeutics, including antibodies
• Define and develop robust biologics drug product manufacturing processes across the portfolio
• 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
• 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 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.)

Preferred Qualifications

• Experience with process validation and commercialization of biologics
• Experience with clinical study support including clinical dose preparation, clinical in-use studies, and support of Pharmacy Manual and/or Investigator’s brochures

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
• 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