Senior Scientist, Sterile Product Development (Onsite)

MSD • Rahway, NJ

2d • Onsite

About The Position

The Sterile Product Development group develops parenteral dosage forms, including long-acting injectables (LAIs) and peptide drug conjugates (PDCs), across small molecules, peptides, and biologics from preclinical development through commercialization. The group develops robust, scalable drug product and delivery solutions using 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.

The Senior Scientist is a hands-on individual contributor who supports scientific development of LAIs, PDCs, and other parenteral formulations. The role independently designs and executes studies, interprets data, and recommends formulation and process development approaches within multidisciplinary teams. It provides technical input and scientific leadership for defined experimental or development workstreams, aligned with project objectives and guidance from project leads. The role also offers informal technical guidance and knowledge sharing to colleagues, without people-management responsibility or overall project-delivery authority.

The position supports early- and late-stage development, including scalable manufacturing process evaluation, characterization of formulation and process variables, design-space definition, clinical and commercial scale-up and validation, and technology transfer to GMP manufacturing facilities. It collaborates with Clinical, Non-Clinical, Quality, Regulatory, Manufacturing, and Engineering colleagues and contributes to CMC regulatory submissions and health authority interactions. The scientist also supports capability development, external collaborations, innovation initiatives, and scientific communications such as patents, presentations, and publications.

Requirements

• Ph.D. with 0 years of industry experience, or M.S. with 4 or more years of industry experience, in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Chemistry, Materials Science, or a related discipline.
• 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 design-of-experiments approaches to formulation and process development.
• Experience contributing experimental or technical support to process scale-up, validation, or technology transfer for sterile injectable products.
• Ability to independently plan and execute studies, interpret complex data, and communicate clear scientific recommendations.
• Ability to collaborate effectively across functions and provide technical leadership within a defined workstream without formal supervisory or project leadership authority.

Nice To Haves

• 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 scientific documentation supporting development-stage and commercial submissions.
• Scientific understanding of controlled-release mechanisms, LAI delivery systems, and relationships between formulation attributes and product performance.
• Scientific understanding of 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, such as dosing interval, injection volume, and administration route.
• Experience with 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.

Responsibilities

• Design, execute, and interpret formulation and process development studies for long-acting injectables, peptide drug conjugates, and conventional parenteral formulations.
• Evaluate formulation approaches suited 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 of formulation stability and product performance, 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; syringeability, injectability, and device compatibility; and chemical stability, peptide and conjugate integrity, and free-drug formation.
• Support early- and late-stage development programs by evaluating and recommending scalable manufacturing processes, characterizing formulation and process variables to support design-space definition, supporting clinical and commercial process scale-up and validation, and transferring technology to GMP manufacturing facilities.
• Collaborate with Clinical, Non-Clinical, Quality, Regulatory, Manufacturing, and Engineering colleagues to identify and characterize critical quality attributes and critical process parameters relevant to LAI and PDC quality, stability, and performance.
• Support clinical strategy through formulation design and risk mitigation, and 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, and 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.

Benefits

• Comprehensive benefits package.
• Medical, dental, vision, healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior