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

  • 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:

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US and Puerto Rico Residents Only:

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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:

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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 thinking and approach problems collectively.

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The salary range for this role is

$173,200.00 - $272,600.00

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 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.  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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

07/14/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.