Senior Scientist, Sterile Product Development (Onsite)

Job Description Role Overview The Sterile Product Development group develops parenteral dosage forms, including long-acting injectables and peptide drug conjugates across small molecules, peptides, and biologics from preclinical development through commercialization. Our teams develop robust, scalable drug product and delivery solutions through scientific understanding of formulation, drug-excipient interactions, delivery system performance, and manufacturing processes, with a focus on product quality, safety, efficacy, and patient‑centric design. Responsibilities Design, execute, and interpret formulation and process development studies for long-acting injectables and peptide drug conjugates, as well as conventional parenteral formulations. Evaluate approaches appropriate to each molecule and product, including polymer-based controlled-release systems and crystalline suspensions for long-acting injectables. Provide scientific input to cross-functional teams on formulation, drug substance properties, delivery system performance, container/closure compatibility, manufacturability, and clinical in‑use considerations. Take technical responsibility for assigned workstreams, communicate findings and risks, and recommend next steps to project leads. Design, conduct, and interpret studies to understand formulation stability and product performance for long-acting injectables and peptide drug conjugates, including release kinetics where relevant. Drug-excipient and drug‑polymer interactions In vitro and in vivo performance relationships Physical stability, solubility, aggregation, and particle size control, as appropriate to the formulation Syringe ability, injectability, and device compatibility Chemical stability of drug substances and formulated products, including peptide and conjugate integrity and formation of free drug in peptide drug conjugates Support early‑ and late‑stage development programs, including: Experimental evaluation and recommendation of scalable manufacturing processes for long-acting injectables and peptide drug conjugates Characterization of formulation and process variables to support definition of design space Support for clinical and commercial process scale‑up and validation Technology transfer to GMP manufacturing facilities Collaborate with Clinical, Non‑Clinical, Quality, Regulatory, Manufacturing, and Engineering colleagues, contributing experimental data and scientific recommendations to: Identify and characterize critical quality attribute and critical process parameters relevant to LAI and PDC quality, stability, and performance Support clinical strategy through formulation design and risk mitigation Contribute to CMC regulatory submissions and health authority interactions Provide scientific leadership within defined workstreams by developing experimental plans, troubleshooting technical challenges, interpreting results, and sharing recommendations. Offer informal technical guidance and knowledge sharing to colleagues without responsibility for people management or overall project delivery. Maintain awareness of emerging LAI technologies and PDC formulation and delivery approaches; contribute scientific assessments and experimental support to capability development, external collaborations, and innovation initiatives aligned with team priorities. Contribute to patents, external presentations, publications, and professional scientific activities related to sterile product development, long‑acting injectables, and peptide drug conjugates. Minimum Education Requirements Ph.D. with 0 years industry experience M.S. with 4+ years industry experience in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Chemistry, Materials Science, or a related discipline Required Experience and Skills Strong scientific foundation and hands‑on or academic experience in parenteral formulation or process development, with relevant experience in long‑acting injectables, sustained‑release formulations, peptides, or drug conjugates, and the ability to apply this experience across LAI and PDC development. Experience applying Quality by Design principles and DOE approaches to formulation and process development. Experience contributing experimental or technical support to process scale‑up, validation, or technology transfer for sterile injectable products. Demonstrated ability to independently plan and execute studies, interpret complex data, and communicate clear scientific recommendations; collaborate effectively across functions and provide technical leadership within a defined workstream without formal supervisory or project leadership authority. Preferred Experience and Skills Experience with LAI platforms such as polymer depots, microspheres, nanosuspensions, or in situ forming systems; experience spanning both LAI and peptide or drug‑conjugate development is particularly valuable. Working knowledge of CMC regulatory expectations for sterile parenteral products and the scientific documentation needed to support development‑stage and commercial submissions. Scientific understanding of the following principles and their application to LAI and PDC development: Controlled‑release mechanisms, LAI delivery systems, and relationships between formulation attributes and product performance Drug‑polymer and drug‑excipient interactions Hands‑on experience developing peptide or peptide drug‑conjugate formulations, including characterization of stability, conjugate integrity, aggregation, free‑drug formation, and compatibility with formulation and manufacturing conditions. Experience with device‑drug product integration, including prefilled syringes or delivery systems relevant to long‑acting injectables. Understanding of clinical and patient‑centric considerations influencing LAI design (e.g., dosing interval, injection volume, administration route). Physical and chemical stability and characterization of parenteral formulations, including peptide/conjugate integrity, aggregation, and free‑drug formation where relevant. 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 Chemistry Data Analysis Drug Delivery Technology Drug Product Development Experience Design Flow Cytometry High‑Throughput Screening Interpersonal Relationships In Vitro Research Molecular Biology Techniques Multi‑Color Flow Cytometry Pharmaceutical Sciences Preformulation Process Development (PD) Process Optimization 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. 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: EEOC Know Your Rights EEOC GINA Supplement 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 primary location for this posting is: USA - New Jersey - Rahway Compensation The salary range for the primary location of this role is: $117,000.00 - $184,200.00 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 . Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location. 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/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 11/4/2026 *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. Requisition ID

R424155