Principal Scientist, Vaccine Drug Product Development

Job Description Vaccine Drug Product Development (VDPD) , a part of our company’s Research Laboratories, is seeking a Principal Scientist to join our department in West Point, PA. Our mission is to develop novel vaccine drug products that will profoundly improve global human health—building on our company’s 50+ year legacy as pioneers in the discovery, development, and manufacturing of novel vaccines to eliminate disease. The department is responsible for developing vaccine adjuvants and drug products from preclinical studies through Phase III clinical trials with a line of sight to commercialization. We ensure robust composition, primary packaging, and process development through a deep fundamental understanding and characterization such that the process is scalable without compromising safety, efficacy, or stability. During development we leverage smart experimental design, cutting‑edge analytical tools, and statistical/predictive approaches to inform formulation and process development. Our team enables the translation of vaccine preclinical candidates from concepts into robust commercial drug products. Primary Responsibilities Lead a matrixed team in the design, execution, and documentation of experiments to develop stable formulations and robust manufacturing processes for preclinical and clinical supply production and to scale‑up these processes to the pilot plant and commercial space. Work independently in a hands‑on, dynamic laboratory environment while collaborating within the group, across functional areas, and with external partners. Provide active strategic and technical leadership on program development teams. Communicate data and conclusions verbally, in written documents and reports, and through technical presentations. Facilitate leadership and communication to manage expectations of stakeholders as part of our stage‑gate process. Lead teams to advance areas such as science and technology innovation, business process improvement, and clinical manufacturing capability build. Mentor less experienced scientists and demonstrate a strong desire to learn and contribute. Maintain an awareness of industry challenges, trends, and opportunities through a strong external scientific network. Maintain a track record of external publication, patenting, and presentations. Required Experience and Skills Ph.D. in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, or related discipline with a minimum of 8 years of relevant industrial experience; or an M.S. degree in a similar field with a minimum of 10 years of relevant industrial experience; or a B.S. degree in a similar field with a minimum of 12 years of relevant industrial experience. Proven written and verbal communication skills. Ability to prioritize, plan, and execute work with limited guidance. Ability to work in a dynamic and fast‑paced team environment. Demonstrated facilitative leadership and influencing skills. Hands‑on laboratory skills. Experience developing vaccine adjuvant and/or vaccine drug product processes, or significant nucleic‑acid and lipid‑nanoparticle experience, including advanced knowledge of key unit operations (freeze/thaw, formulation, mixing, filtration, filling, stoppering, etc.). Understanding of vaccine adjuvant and/or drug product quality attributes, specifications, characterization techniques, and product vulnerabilities and mitigation strategies. Experience with engineering principles used in process development and process scale‑up/scale‑down. Experience with technical transfer of processes from lab to pilot plant and/or commercial sites including the use of risk assessment tools. Track record of difficult technical problem solving. Ability to develop and implement new methods/processes. Experience with GMP manufacturing of clinical supplies. Experience with use of statistical principles to understand, predict, and communicate process robustness. Experience with root‑cause analysis and investigations (FMEA, fishbone, etc.). Experience authoring regulatory filings for sterile dosage forms (adjuvants and/or drug products). Experience responding to regulatory questions related to drug products. Experience, desire, and a track record of effective mentorship of less experienced scientists toward time‑bound goals. Desired Experience and Skills Experience with sterile product manufacturing and aseptic technique. Experience with colloidal systems and characterization of colloids, including emulsions. Familiar with ISO, CFR, ICH, and USP guidelines as they relate to sterile products. Familiar with Quality by Design principles and experience applying the QbD tools and principles to products in development. Experience with process modeling. Experience with liquid and lyophilized drug product formulation development. Understanding of compliance and regulatory issues for sterile injectable products manufactured by aseptic processing. Experience with direct people management. Equal Employment Opportunity Statement 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. Compensation and Benefits Salary range: $173,200.00 – $272,600.00. The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, health‑care and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. #J-18808-Ljbffr Merck