Associate Principal Scientist, Upstream Development

Job Overview Associate Principal Scientist in the Biologics Process Development Department within our Research Laboratories. Responsible for developing the drug substance manufacturing processes for the biologics pipeline, collaborating across Discovery, Pre‑clinical, Early Development, and Manufacturing to design, develop, and optimize cell culture processes and transfer to clinical and commercial manufacturing sites. Responsibilities Lead upstream process development of first-in-human and commercial processes to develop high‑yield, robust, scalable cell culture processes. Conduct process development, characterization, and regulatory filing activities to support successful PPQ and BLA submissions. Partner with cross‑functional teams (Discovery, Cell Line, Downstream Process Development, Analytical Sciences, Manufacturing) to develop integrated clinical and commercial process solutions with quality‑by‑design targets. Advance the upstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs. Collaborate with academia, industry partners, and vendors to drive innovation and adoption of new process technologies. Keep current on external patent and literature environment; actively present, publish, and pursue patent strategies. Minimum Education Requirements Ph.D. with 4+ years' experience OR Master’s with 8+ years' experience OR Bachelor's with 12+ years' experience in chemical engineering, bioengineering, biological engineering, or related field. Required Experience and Skills Hands‑on experience with mammalian cell culture and fed‑batch processes to produce recombinant proteins. Understanding of CHO cell biology, metabolism, media, and engineering principles for large‑scale production. Knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (SIMCA, JMP, etc.). Experience with cell culture bioreactors, microbioreactors, bench‑scale and pilot‑scale, and scale‑up principles. Track record of upstream process and technology development with strong publication and presentation record. Ability to plan, execute, analyze, and document all stages of cell culture process development. Excellent verbal, written communication, and interpersonal skills. Ability to work effectively in cross‑functional, matrixed teams and collaborate with internal and external partners. Initiative, creativity, and innovation in problem solving. Productivity and efficiency in laboratory work. Ability to deliver complex objectives under aggressive timelines. Preferred Experience and Skills Cell culture media development. High‑throughput microbioreactor systems and advanced in‑situ analytics for process monitoring. State‑of‑the‑art cell culture processes including intensified inoculum/fed‑batch and perfusion development. Data science approaches related to cell culture (metabolic flux analysis, omics, machine learning, CFD) and PAT integration. Late‑stage commercial process development, technology transfer, scale‑down model qualification, and process characterization. Knowledge of biologics CMC development cycle and scale‑up/down and tech transfer to GMP sites. Salary and Benefits Salary range: $142,400.00 – $224,100.00. Eligible for annual bonus and long‑term incentive if applicable. Comprehensive benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days. Equal Employment Opportunity We are an equal opportunity employer. We prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, and other protected characteristics. Additional information: see EEOC. #J-18808-Ljbffr Merck & Co.