Original listing text, shown exactly as published by the company.
Key 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.)
Ideal Candidate
- 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.
The anticipated salary range for candidates for this role will be $210,000 to $235,000 year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
