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Apogee Therapeutics · 9 hours ago

Director, Drug Product Development

United States

Full-time

Hybrid

Director/Executive

$210K/yr - $235K/yr

10+ years exp

Apogee Therapeutics is a biotechnology company focused on developing differentiated biologics for the treatment of various inflammatory and immunology indications. The Director, Drug Product Development will oversee the development of protein drug product presentations and processes, manage tech transfer to manufacturing partners, and ensure robust drug product supply for clinical trials and commercialization.

BiotechnologyLife ScienceMedicalTherapeutics

H1B Sponsor Likely

Responsibilities

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.)

Qualification

Drug product developmentAseptic manufacturingGMP operationsBiologics expertiseProcess performance qualificationTech transfer managementRegulatory submissionsCommunicationCollaboration skills

Required

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

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

Preferred

Experience with pre-approval inspection (PAI) readiness and support is preferred

Experience with drug product process extractables / leachables risk assessments is preferred

Benefits

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

Company

Apogee Therapeutics

Apogee Therapeutics is a biotechnology company that offers therapies for immunological and inflammatory disorders.

Founded in 2022

San Francisco, California, USA

201-500 employees

https://apogeetherapeutics.com/

H1B Sponsorship

Apogee Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (3)