Director, Sterile Product Sterility Assurance

Job Description

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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

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