Scientist, Preclinical Dev.

Role Summary Vaccines and Advanced Biotechnologies Process R&D (VaxPRD) is responsible for the development and clinical manufacturing of Drug Substance (DS) and Drug Product Intermediates (DPI) for the vaccine and advanced therapy pipeline, spanning from preclinical to commercialization stages. We are part of the Process R&D organization, which enables modality‑agnostic DS/DP process development and clinical manufacturing for our company's pipeline. Our vaccines upstream process development team develops safe, scalable, robust, cost‑effective upstream processes that enable clinical and commercial manufacture of vaccines and adjuvants across all vaccine modalities. Under the direction of the group leader, the individual will be responsible for upstream process development of vaccine candidates. The successful candidate will plan, perform, and critically evaluate lab scale process development and scale‑up studies, develop robust, efficient, scalable processes for vaccine production, and support transfer of processes to clinical or commercial manufacturing facilities. The individual is expected to function in a multidisciplinary environment, contributing subject matter expertise to teams engaged in development and clinical manufacture of vaccine candidates. This position requires the employee to be willing to work with infectious agents and/or pathogens and may require occasional travel and off‑hour/weekend work. Key Responsibilities Design, execute, and analyze process development experiments to maximize understanding of cell culture and fermentation processes to enable robust vaccine manufacturing. Conduct laboratory bench work to execute, optimize, and troubleshoot cell culture and fermentation processes (e.g., shake flasks, bench scale and pilot scale bioreactors). Apply data analysis and basic data science/modeling approaches (e.g., statistics, design of experiments) to design experiments, interpret datasets, and support process understanding and optimization. Contribute to the development and scale‑up of upstream processes from lab scale to pilot scale and support technology transfer to manufacturing scale. Perform upstream unit operations as needed, including lab scale cell culture, fermentation, centrifugation, filtration, and in‑process assays. Maintain and coordinate raw material and equipment inventories; ensure equipment is operated and maintained in a safe, compliant manner. Prepare clear technical reports and presentations to summarize and communicate experimental results and recommendations in a collaborative team environment. Mentor and provide technical guidance to contract staff or new hires in laboratory techniques and best practices, as appropriate. Keep accurate, detailed laboratory records; comply with all required training and maintain a strong focus on laboratory/facility safety for self and team members. Contribute to the development of new principles, concepts, and methods to enable process development, scale‑up of processes to pilot scale, and technology transfer to manufacturing scale. Education Minimum Requirement BS or MS in a relevant field such as Engineering: Chemical Engineering, Bioengineering, Biomedical Engineering or Science and Technology: Biological Sciences, Biochemistry, Biotechnology, Cell Biology. Required Experience and Skills For BS: at least two (2) years of post‑graduate experience in a bioprocess/biotechnology related position (vaccines and/or therapeutic proteins). For MS: at least one (1) year of post‑graduate experience in a bioprocess/biotechnology related position (vaccines and/or therapeutic proteins) or relevant academic research thesis. Strong scientific understanding of fermentation and/or cell culture processes, with hands‑on experience in bioprocess development. Excellent scientific understanding of cell biology relevant to vaccine production, including cell metabolism and molecular biology. Demonstrated proficiency with bench scale bioreactors, shake flasks, or other cell propagation systems for optimization of cell culture or fermentation processes. Demonstrated ability to perform quantitative data analysis (e.g., statistical analysis of experimental data using software tools for data handling and visualization). Ability to work independently and as part of a team; strong self‑motivation, adaptability, and a positive attitude. Ability to learn new techniques, balance multiple projects, keep accurate records, follow instructions, and comply with company policies. Excellent organization, interpersonal, verbal, and written communication skills. Willingness to work with infectious agents and/or pathogens. Willingness to travel occasionally and to work off‑hours/weekends as needed to support operations or technology transfer. Preferred Experience and Skills Experience with data science and modeling tools (e.g., statistics, design of experiments, and/or coding/scripting such as Python or similar tools for data analysis and modeling). Prior experience with lab scale (5 L–200 L) bioreactors. Prior experience in optimizing recombinant protein expression (quality and quantity of product). Direct experience with upstream bioprocess unit operations (e.g., cell culture, bioreactors, centrifugation, filtration, in‑process analytics) in an industrial environment. Prior experience with the application of PAT for monitoring upstream bioprocesses. Prior experience with the application of systems biology approaches (e.g., “-omics”) to increase process understanding and/or solve upstream bioprocess challenges. Sound understanding of process scale‑up principles. Prior experience with fermentation bioprocesses (e.g., E. coli, yeast) or mammalian bioprocesses (e.g., CHO, HEK293, Vero). Other Information Salary range: $87,300.00 - $137,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. Benefits include medical, dental, vision, and other insurance benefits, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity statement: 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 legally protected characteristics. Travel required: 10%. Employment type: regular. Relocation: no. Visa sponsorship: no. Flexible work arrangements: hybrid. Shift: 1st – Day. #J-18808-Ljbffr Merck