Director, Drug Product Development
Apogee Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $210,000 - $235,000 per year
Job Level
About the role
- 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, 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
PFS process developmentGMP manufacturingprocess performance qualification (PPQ)risk assessmentsbiologics drug product process developmentaseptic manufacturingtech transferformulation developmentco-formulation developmentregulatory submissions
Soft skills
leadershipcollaborationcommunicationstrategic insightstechnical guidanceproblem-solvingcross-functional teamworkanalytical skillsprocess improvementstakeholder engagement
Certifications
PhD in chemical engineeringPhD in biochemical engineeringPhD in chemistry