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Director, Drug Product Development

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Apogee Therapeutics

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Location:
United States

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

210000.00 - 235000.00 USD / Year
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Job Description:

We are seeking a Director, 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 prefilled syringes (PFS), combination product development, and compliance, while fostering collaboration across teams and external partners. This person will be a subject matter expert in drug product manufacturing, including PFS, within the CMC organization, providing strategic guidance and technical leadership across cross-functional teams.

Job Responsibility:

  • Serve as a subject matter expert in PFS 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
  • 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 performance qualification (PPQ), and commercial readiness
  • Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies
  • Collaborate with drug product development and device teams to develop drug product presentations in vial, PFS, autoinjector, and advanced delivery technologies
  • Analyze manufacturing data and identify opportunities for process improvement and optimization
  • Support formulation and co-formulation development for protein therapeutics, including antibodies
  • 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.)

Requirements:

  • Minimum of 10 years industry experience in drug product development and manufacturing
  • 5+ years of experience in clinical and/or commercial Good Manufacturing Practice (GMP) operations for PFS drug products
  • 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 performance qualification (PPQ) and commercialization of biologics
  • Excellent communication skills
  • Availability to participate in calls across international time zones
  • Position requires up to 25% travel including travel to domestic and international sites. In person attendance at Apogee All Hands meetings is required, typically held twice per year.

Nice to have:

  • Experience with pre-approval inspection (PAI) readiness and support is preferred
  • Experience with drug product process extractables / leachables risk assessments is preferred
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
  • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
  • 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

Additional Information:

Job Posted:
January 13, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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