Principal Scientist, Long-Acting Injectable Sterile Product Development

Job Description 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. Primary Duties Serve as a principal-level 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 strategy development, 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 strategic 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, 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 Minimum Education Requirements Ph.D. with 7+ years industry experience, or M.S. with 10+ years, or B.S. with 14+ 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 Design-of-Experiments 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 Proven mentoring and scientific leadership skills at the senior/principal level Preferred Experience and Skills Experience with 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 Salary range: $173,200.00 - $272,600.00 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. US and Puerto Rico Residents Only. Equal Employment Opportunity 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 • Learn more about your rights, including under California, Colorado and other U.S. State Acts. #J-18808-Ljbffr Merck & Co.