Rahway, New Jersey, United States
Onsite
Available
Job Description
Overview:
The Sterile Product Development group is responsible for the development of parenteral dosage forms, including long‑acting injectables (LAIs), across small molecules, peptides, and biologics from preclinical development through commercialization. Our teams enable robust and scalable drug product and delivery solutions through deep scientific understanding of formulation, drug–excipient interactions, delivery system performance, and manufacturing processes, ensuring product quality, safety, efficacy, and patient‑centric design.
This role is an Associate Principal Scientist–level technical leadership position with a primary focus on long‑acting injectable drug products, including depot formulations, extended‑release systems, and injectable sustained‑delivery technologies. The successful candidate will serve as a scientific leader across multidisciplinary teams, shaping LAI formulation and development strategy across the portfolio.
Primary Duties
Serve as an LAI formulation scientist, providing scientific leadership for the design, development, and lifecycle management of long‑acting injectable drug products, including depot, sustained‑release, and controlled‑delivery parenteral dosage forms
Lead LAI formulation and delivery development for one or more programs, including selection and optimization of release mechanisms (e.g., polymer‑based depots, suspensions, microspheres, in situ forming systems), excipient systems, and delivery approaches to meet target product profiles
Provide technical leadership on cross‑functional program teams, ensuring alignment of formulation, drug substance properties, delivery system performance, container/closure systems, manufacturability, and clinical use considerations throughout development
Design and interpret studies to understand and control release kinetics, stability, and performance, including:
Drug–excipient and drug–polymer interactions
In vitro and in vivo performance relationships
Physical stability, aggregation, and particle size control
Syringeability, injectability, and device compatibility
Support early‑ and late‑stage development programs, including:
Selection of scalable manufacturing processes for LAIs
Definition of formulation and process design space
Support for clinical and commercial process scale‑up and validation
Technology transfer to GMP manufacturing facilities
Partner closely with Clinical, Non‑Clinical, Quality, Regulatory, Manufacturing, and Engineering teams to:
Define critical quality attributes (CQAs) and critical process parameters (CPPs) relevant to LAI performance
Support clinical strategy through formulation design and risk mitigation
Contribute to CMC regulatory submissions and health authority interactions
Provide scientific oversight and mentoring to junior scientists on project teams, fostering capability development in LAI formulation science, experimental design, and data‑driven decision making
Maintain awareness of emerging LAI technologies and delivery platforms, contributing to internal capability assessments, external collaborations, and innovation initiatives aligned with portfolio and organizational strategy
Enhance our Company’s professional image and competitive advantage through generation of patents, external presentations, publications, and professional organizations related to sterile product development and/or long-acting injectables
Minimum Education Requirements
Ph.D. with 4+ years industry experience, or
M.S. with 8+ years, or
B.S. with 10+ years
in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Chemistry, Materials Science, or a related discipline
Required Experience and Skills
Deep expertise in parenteral drug product development, with demonstrated experience in long‑acting injectable or sustained‑release formulations
Strong scientific understanding of:
Controlled‑release mechanisms and LAI delivery systems
Drug–polymer and drug–excipient interactions
Formulation stability and performance characterization
Experience applying Quality by Design (QbD) principles and DOE approaches to formulation and process development
Experience supporting process scale‑up, validation, and technology transfer for sterile injectable products
Working knowledge of CMC regulatory expectations for parenteral and extended‑release products, including development‑stage and commercial submissions
Demonstrated ability to lead cross‑functional teams, influence strategy, and communicate complex scientific concepts clearly
Preferred Experience and Skills
Experience with several LAI‑specific platforms, such as polymer depots, microspheres, nanosuspensions, or in situ forming systems
Experience with device–drug product integration, including prefilled syringes or delivery systems relevant to LAIs
Understanding of clinical and patient‑centric considerations influencing LAI design (e.g., dosing interval, injection volume, administration route)
Experience supporting global regulatory filings and health authority interactions
Track record of contributing to publications, patents, or external scientific collaborations in drug delivery or formulation science
Required Skills:
Bioprocess Engineering, Bioprocess Engineering, Cell Line Development, Chemical Engineering, Downstream Process Development, Drug Delivery, Drug Delivery Technology, Drug Development, Drug Formulations, Early Phase Clinical Trials, Expression Vectors, Kinetics, Molecular Biology, Pharmaceutical Formulations, Pharmaceutical Process Development, Pharmaceutical Products, Pharmaceutical Research, Pharmaceutical Sciences, Pharmaceutical Technologies, Pharmaceutics, Physical Characterization, Product Development Lifecycle, Product Formulation, Regulatory Submissions, Stable Cell Lines {+ 1 more}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:
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.
Learn more about your rights, including under California, Colorado and other US State Acts
The salary range for this role is
$142,400.00 - $224,100.00This 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:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
09/19/2026*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.
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