Director, Drug Product Development

Location

United States

Posted

137 days ago

Salary

$210K - $235K / year

Seniority

Lead

Postgraduate Degree10 yrs expEnglish

Job Description

Director, Drug Product Development

Apogee Therapeutics

• 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.)

Job 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, 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 performance qualification (PPQ) and commercialization of biologics
  • Experience with pre-approval inspection (PAI) readiness and support is preferred
  • Experience with drug product process extractables / leachables risk assessments is 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
  • 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.

Benefits

  • 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

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