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Director, Drug Product Development

2 hours, 1 minute ago
United States
Full-time
Lead
Operations Manager
Operations
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 17

Description

  • Serve as the subject matter expert for prefilled syringe (PFS) process development and manufacturing.
  • Develop late-phase and commercial launch strategies for PFS development and manufacturing.
  • Oversee drug product tech transfer, process development, and GMP manufacturing operations, including person-in-plant support.
  • Manage CDMO performance against deliverables, timelines, and manufacturing expectations in partnership with Quality and Tech Ops.
  • Support phase-appropriate development strategies, scale-up, process characterization, PPQ, and commercial readiness.
  • Perform risk assessments using a QbD approach to guide development and manufacturing decisions.
  • Collaborate with drug product and device teams on presentations in vial, PFS, autoinjector, and advanced delivery formats.
  • Analyze manufacturing data to identify process improvements and optimization opportunities.
  • Support formulation and co-formulation development for protein therapeutics, including antibodies.
  • Work with Quality and external partners to review and approve batch records, support investigations, and resolve deviations.
  • Author and review regulatory submissions, including INDs, IMPDs, BLAs, and briefing books.

Requirements

  • Minimum of 10 years of industry experience in drug product development and manufacturing.
  • 5+ years of experience in clinical and/or commercial GMP operations for PFS drug products.
  • Demonstrated leadership in GMP manufacturing of combination products.
  • PhD in a relevant discipline such as chemical engineering, biochemical engineering, chemistry, or a related field, or equivalent education and experience.
  • Proven expertise in biologics drug product process development and aseptic manufacturing, preferably for 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 extractables and leachables risk assessments is preferred.
  • Demonstrated ability to collaborate with cross-functional stakeholders across development, quality, regulatory, supply chain, device, clinical, and operations teams.
  • Excellent communication skills with the ability to convey information clearly and concisely.
  • Availability to participate in calls across international time zones.
  • Ability to travel up to 25%, including domestic and international sites, and attend in-person Apogee All Hands meetings twice per year.

Benefits

  • Base salary range of $210,000 to $235,000 per year.
  • Market-competitive compensation package with performance bonus and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, plus two one-week company-wide shutdowns each year and paid sick leave.
  • Opportunities for professional growth and access to development resources.
  • Regular all-team in-person meetings to build relationships and solve problems.
  • Opportunity to work in a fast-paced, highly dynamic environment with the ability to help shape the company culture.

Interested in this position?

Apply directly on the company website

Apply Now

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