Director, Sterile Product Sterility Assurance

About the role

The Mixed Modalities team within Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, ophthalmic and inhaled products) for small molecules, intermediate modalities, and biologics from preclinical development through commercialization. Our development teams ensure robust formulation, primary packaging, sterilization strategy, and manufacturing process selection through deep scientific understanding and characterization, enabling scalable processes without compromising product quality, safety, efficacy, or delivery.

Responsibilities

• Serve as a principal level sterilization scientist, providing technical leadership for sterilization strategy, sterility assurance, and contamination control for sterile drug products, including injectable, ophthalmic, implantable, and inhaled dosage forms.
• Define, evaluate, and implement sterilization strategies across development stages, including moist heat, vaporized hydrogen peroxide (VHP), alternative low temperature technologies, and aseptic processing when terminal sterilization is not feasible.
• Provide strategic technical leadership on cross-functional program teams, ensuring robust integration of formulation, container/closure systems, device compatibility, sterilization feasibility, and sterility assurance throughout development.
• Lead or contribute to sterilization, washing, and decontamination cycle development and validation, including: Cycle design aligned with user requirements specifications (URS), product and packaging constraints, and regulatory expectations; Thermal and microbiological mapping studies; Application of biological indicators, endotoxin control strategies, and sterility assurance principles; Evaluation of process residuals (e.g., moisture, hydrogen peroxide, NO2, ETO) and their impact on product quality, container closure integrity, and packaging performance.
• Work with cross-functional SME’s from devices, packaging, Tech Ops and other functions to lead the Sterilant selection for a given product profile, based on product impact analysis, cycle time, facility fit, long term sustainability and other factors.
• Contribute to and influence regulatory submissions by authoring or reviewing sterilization- and CMC-related sections and supporting interactions with health authorities.
• Support early- and late-stage development programs by providing sterilization-focused input into scalable manufacturing processes, primary packaging selection, and compatibility assessments for processing, storage, and administration.
• Mentor and technically guide scientists and engineers, fostering capability development in sterile product development, sterilization sciences, and GMP compliance.
• Build and maintain a strong internal and external professional network, including engagement with academic institutions, vendors, and regulatory bodies; contribute to knowledge dissemination through training, publications, or technical forums as appropriate.

Requirements

Ph.D. with 8+ years industry experience, or M.S. with 10+ years, or B.S. with 12+ years in Chemical Engineering, Biochemical Engineering, Pharmaceutics, Pharmaceutical Sciences, Microbiology, Chemistry, Biochemistry, or a related discipline.

Skills

• Demonstrated hands-on and strategic experience in sterilization science, including: Sterilization cycle development and validation; Sterility assurance, microbiology, and environmental monitoring; Endotoxin control and contamination control strategies; Decontamination and disinfection processes; Strong understanding of sterilization technologies for pharmaceutical products, medical devices, and combination products, including risk-based selection of terminal vs. aseptic approaches; Proven experience with process scale-up, validation, and technology transfer, including collaboration with manufacturing sites and equipment vendors; Working knowledge of FDA, ICH, and global regulatory expectations related to sterilization, aseptic processing, and CMC; Demonstrated scientific leadership, strong communication skills, and a track record of mentoring and developing junior scientists; Ability to operate effectively in cross-functional, matrixed teams and drive decisions in complex technical environments.

Preferred Skills

• Development and Commercialization experience with Intravitreal product development and launch; Direct experience with working with contract sterilization service providers to develop recipe, transfer to manufacturing sites, and oversight of validation activities; Experience with RTU container sterilization challenges, including glass vial decontamination and low-temperature sterilization alternatives; Knowledge of sterile equipment and facility design standards, including involvement in capital project teams and familiarity with FAT, SAT, and qualification/validation activities; Track record of supporting or influencing global regulatory filings and inspection readiness; Experience delivering technical training or workshops related to sterilization, GMP compliance, or contamination control.

Benefits

The salary range for this role is $173,200.00 - $272,600.00. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.