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 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 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: **
Biopharmaceutics, Combination Products, Contamination Control, Data Analysis, EtO Sterilization, GMP Compliance, Intravitreal Injections, Manufacturing Processes, Ophthalmology, Pharmaceutical Process Development, Process Manufacturing, Process Scale Up, Regulatory Filings, Sterile Products, Sterilization, Sterilization Techniques, Syringe Filling, Technology Transfer
**Preferred Skills: **
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U.S. Hybrid Work Model
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 presence.This 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
$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
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**Employee Status: **
Regular
Relocation:
Domestic/International
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
05/23/2026
***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. **