Director, Sterile Product Sterility Assurance

Job description

Job Description NOTICE FOR INTERNAL APPLICANTS: Please review the Global Job Posting and Employee Placement Policy to learn more about what you need to consider before applying for a role. It is important for employees to self-assess that they meet the criteria before moving forward in the application process. Director, Sterile Product Sterility Assurance (P5) Overview 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. This role is a technical leadership position with a strong focus on sterilization science and sterility assurance across drug products, primary containers, devices, and combination products, with specific focus on Intravitreal Product Development. The successful candidate will serve as a sterilization subject matter expert (SME), influencing development strategy, regulatory approaches, and manufacturing readiness for sterile products navigating transversally between fill finish, combination product, sterile barrier packaging and terminal surface sterilization areas. Primary Duties 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 Minimum Education 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 Required Experience and 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 Experience applying Quality by Design (QbD) principles and DOE methodologies to formulation, process, and sterilization development 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 Experience and 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 Required Skills: Bioanalytical Techniques, Biopharmaceuticals, Biopharmaceutics, Chemical Engineering, Combination Products, Computer Aided Engineering (CAE), Design Integration, Ethylene Oxide Sterilizers, Functional Test Planning, GMP Compliance, Innovation, Manufacturing Processes, Microbiology, Persuasion, Pharmaceutical Sciences, Pharmacokinetics, Product Design, Technology Transfer Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thi