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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 a 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 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, Union Beach, NJOn-Site Research Chemistry Visionary Innovation Collections Scale (Map) Food Science Distillation Wet Chemistry Detail Oriented Beverage Products Technical Management Laboratory Equipment Artificial Intelligence Engineering Design Process Good Laboratory Practice (GLP) Gas Chromatography Mass Spectrometry High-Performance Liquid Chromatography +0 Assistant Team Leader Actalent Secaucus, NJRemote AutoCAD Planning Visionary Scheduling Leadership Innovation Coordinating Civil Engineering Working at Heights Artificial Intelligence Engineering Design Process MicroStation (CAD Design Software) +0

Patents, Chemistry Leadership Management Mentorship Innovation Compassion Scalability Cell Cultures Process Design Pharmaceuticals Risk Mitigation Quality Control Small Molecules Telephone Skills Sterile Products Parenteral Drugs Commercialization Materials Science Chemical Kinetics Biopharmaceuticals Influencing Skills Regulatory Filings Quality Management Strategic Thinking Process Development Technology Transfer Formulation Science Contingent Workforce Lifecycle Management Technical Leadership Chemical Engineering Combination Products Device Compatibility Strategy Development Project Manufacturing Capability Assessment Cell Line Development Capability Development Particle Size Analysis New Product Development Manufacturing Processes Target Product Profiles Organizational Strategy Quality By Design (QbD) Pharmaceutical Sciences Biochemical Engineering Data-Driven Decision Making Scale-Up Process Management Good Manufacturing Practices Influencing Without Authority Finite Element Analysis (FEA), * 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 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
• 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

Required Skills: Cell Culture Process Development, Cell Line Development, Chemical Engineering, Combination Products, Finite Element Analysis (FEA), GMP Compliance, Pharmaceutical Process Development, Pharmaceutical Sciences, Project Manufacturing, Quality by Design, Quality Control Management, Quality Management, Stability Calculations, Strategic Thinking, Technology Transfer, Data Analysis Data Security Detail Oriented Microsoft Excel Risk Management Compliance Risk Microsoft Office Ad Hoc Reporting Data Warehousing Analytical Skills Quality Assurance Loan Documentation Workflow Management Microsoft PowerPoint Credit Risk Management Business Administration Web Application Security Document Management Systems Standard Operating Procedure Ethical Standards And Conduct Customer Relationship Management +0

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

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.