Principal Scientist, Intravitreal Product Development
Merck
11 days ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Primary Duties
- Serve as a principal sterilization scientist providing technical leadership for sterilization strategy, sterility assurance, and contamination control for sterile drug products (injectable, ophthalmic, implantable, inhaled).
- Define, evaluate, and implement sterilization strategies across development stages, including moist heat, VHP, alternative low-temperature technologies, and aseptic processing when terminal sterilization is not feasible.
- Provide strategic technical leadership on cross-functional program teams to integrate formulation, container/closure systems, device compatibility, sterilization feasibility, and sterility assurance.
- Lead/contribute to sterilization, washing, and decontamination cycle development and validation, including cycle design (URS/product/packaging/regulatory alignment), thermal and microbiological mapping, biological indicators/endotoxin control/sterility assurance principles, and evaluation of process residuals (moisture, hydrogen peroxide, NO2, ETO) on product quality, CCI, and packaging performance.
- Lead sterilant selection with cross-functional SMEs (devices, packaging, Tech Ops) based on product impact, cycle time, facility fit, long-term sustainability, etc.
- Author/review sterilization- and CMC-related regulatory submission sections and support health authority interactions.
- Provide sterilization-focused input to scalable manufacturing processes, primary packaging selection, and compatibility assessments.
- Mentor and technically guide scientists and engineers; build capabilities in sterile product development, sterilization sciences, and GMP compliance.
Minimum Education
- Ph.D. with 6+ years industry experience, or M.S. with 8+ years, or B.S. with 10+ years in relevant disciplines.
Required Experience and Skills
- Deep sterile drug product development expertise in cGMP environments (preclinical to commercial).
- Hands-on and strategic sterilization science: cycle development/validation; sterility assurance, microbiology, environmental monitoring; endotoxin/contamination control; decontamination/disinfection.
- Risk-based understanding of terminal vs aseptic approaches for pharmaceutical/medical device/combination products.
- QbD and DOE experience across formulation, process, and sterilization development.
- Process scale-up, validation, and technology transfer (manufacturing sites/equipment vendors).
- Working knowledge of FDA/ICH/global regulatory expectations for sterilization, aseptic processing, and CMC.
- Scientific leadership, communication, and mentoring; effective in cross-functional matrixed teams.
Preferred Experience and Skills
- Intravitreal product development and launch.
- Experience with contract sterilization service providers (recipe development, transfer, validation oversight).
- RTU container sterilization challenges (e.g., glass vial decontamination, low-temperature alternatives).
- Sterile equipment/facility design standards; capital projects; FAT/SAT; qualification/validation.
- Support for global regulatory filings/inspection readiness; deliver technical training/workshops.
Required/Preferred Skills (examples)
- Biopharmaceutics; Combination Products; Contamination Control; Data Analysis; EtO Sterilization; GMP Compliance; Intravitreal Injections; Manufacturing/Process Scale-Up; Regulatory Filings; Sterile Products; Sterilization/Techniques; Syringe Filling; Technology Transfer.
Application Instructions
- Apply via https://jobs.merck.com/us/en (deadline stated on posting).
- Serve as a principal sterilization scientist providing technical leadership for sterilization strategy, sterility assurance, and contamination control for sterile drug products (injectable, ophthalmic, implantable, inhaled).
- Define, evaluate, and implement sterilization strategies across development stages, including moist heat, VHP, alternative low-temperature technologies, and aseptic processing when terminal sterilization is not feasible.
- Provide strategic technical leadership on cross-functional program teams to integrate formulation, container/closure systems, device compatibility, sterilization feasibility, and sterility assurance.
- Lead/contribute to sterilization, washing, and decontamination cycle development and validation, including cycle design (URS/product/packaging/regulatory alignment), thermal and microbiological mapping, biological indicators/endotoxin control/sterility assurance principles, and evaluation of process residuals (moisture, hydrogen peroxide, NO2, ETO) on product quality, CCI, and packaging performance.
- Lead sterilant selection with cross-functional SMEs (devices, packaging, Tech Ops) based on product impact, cycle time, facility fit, long-term sustainability, etc.
- Author/review sterilization- and CMC-related regulatory submission sections and support health authority interactions.
- Provide sterilization-focused input to scalable manufacturing processes, primary packaging selection, and compatibility assessments.
- Mentor and technically guide scientists and engineers; build capabilities in sterile product development, sterilization sciences, and GMP compliance.
Minimum Education
- Ph.D. with 6+ years industry experience, or M.S. with 8+ years, or B.S. with 10+ years in relevant disciplines.
Required Experience and Skills
- Deep sterile drug product development expertise in cGMP environments (preclinical to commercial).
- Hands-on and strategic sterilization science: cycle development/validation; sterility assurance, microbiology, environmental monitoring; endotoxin/contamination control; decontamination/disinfection.
- Risk-based understanding of terminal vs aseptic approaches for pharmaceutical/medical device/combination products.
- QbD and DOE experience across formulation, process, and sterilization development.
- Process scale-up, validation, and technology transfer (manufacturing sites/equipment vendors).
- Working knowledge of FDA/ICH/global regulatory expectations for sterilization, aseptic processing, and CMC.
- Scientific leadership, communication, and mentoring; effective in cross-functional matrixed teams.
Preferred Experience and Skills
- Intravitreal product development and launch.
- Experience with contract sterilization service providers (recipe development, transfer, validation oversight).
- RTU container sterilization challenges (e.g., glass vial decontamination, low-temperature alternatives).
- Sterile equipment/facility design standards; capital projects; FAT/SAT; qualification/validation.
- Support for global regulatory filings/inspection readiness; deliver technical training/workshops.
Required/Preferred Skills (examples)
- Biopharmaceutics; Combination Products; Contamination Control; Data Analysis; EtO Sterilization; GMP Compliance; Intravitreal Injections; Manufacturing/Process Scale-Up; Regulatory Filings; Sterile Products; Sterilization/Techniques; Syringe Filling; Technology Transfer.
Application Instructions
- Apply via https://jobs.merck.com/us/en (deadline stated on posting).