Principal Scientist, Intravitreal Product Development

Job Description

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 SMEs 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 latestage development programs by providing sterilizationfocused 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 6 years industry experience or

• M.S. with 8 years or

• B.S. with 10 years
  in Chemical Engineering Biochemical Engineering Pharmaceutics Pharmaceutical Sciences Microbiology Chemistry Biochemistry or a related discipline

Required Experience and Skills

• Deep expertise in sterile drug product development across preclinical clinical and commercial stages within a cGMP-regulated environment

• 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:

Preferred Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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. Available benefits include 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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