Associate Principal Scientist, Process Analytical Technologies

Overview We are seeking an experienced and innovative Associate Principal Scientist to join the Process Analytical Technologies (PAT) team within Analytical Enabling Capabilities. In this role, you will collaborate with a cross-functional, highly engaged team to advance the development pipeline and support commercial manufacturing. The successful candidate will lead the development, validation, and implementation of in-line, on-line, and at-line PAT solutions for both small- and large-molecule modalities. Join our company and contribute to our mission of delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals. Responsibilities Provide technical leadership for systematic assessment and deployment of in-line, on-line, and at-line PAT methods across small- and large-molecule programs. Design and develop standardized analytical platforms to enable PAT implementation, including real-time monitoring and rapid shop-floor analytics. Develop, validate, and implement PAT methods (in-line, on-line, at-line) to monitor and control process parameters and product quality attributes. Lead scale-up activities and technology transfer of PAT applications to commercial manufacturing. Partner with capital project and facility teams to design and establish integrated PAT infrastructure aligned with the Launch Preparedness strategy. Create integrated control strategies that leverage PAT platforms to enable robust, highly capable manufacturing processes across modalities (e.g., small molecule drug product, biologics, and vaccines). Prepare and maintain scientific documentation and validation packages for PAT methods; contribute content for regulatory submissions. Interact with global regulatory agencies as needed to support acceptance of PAT-based process control and release strategies. Qualifications B.S. in chemistry, biochemistry, biotechnology, bioengineering, chemical engineering, or a related discipline with a minimum of 12 years of relevant industry experience; or M.S. with at least 8 years; or Ph.D. with at least 4 years. Demonstrated experience in PAT. Strong technical background in spectroscopy (Raman, FTIR, NIR), chromatography, and chemometric/modeling approaches. Proven track record of scientific contributions (peer-reviewed publications or equivalent technical outputs). Preferred Experience preparing PAT content for regulatory filings and interacting with regulatory agencies. Experience with PAT implementation in commercial manufacturing and technology transfer. Strong collaborative and interpersonal skills; ability to work across functions and with external partners. Project leadership and the ability to manage multiple priorities in a fast-paced environment. Required Skills Adaptability, Analytical Method Development, Assay Development, Biodesign, Biological Assay Development, Cell-Based Assays, Chemical Engineering, Chemometrics, Chromatographic Techniques, Chromatography, Cross-Functional Collaboration, Cross-Functional Teamwork, External Collaboration, High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Process Analytical Technology (PAT), Project Leadership, Real Time Monitoring Additional Information US And Puerto Rico Residents Only Our company is committed to inclusion and provides accommodations during the application or hiring process if needed. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on protected characteristics. Salary range: $142,400.00 - $224,100.00. Eligible for annual bonus and long-term incentive, if applicable. Hybrid work model in the U.S. with three on-site days per week (details in posting). Travel requirements: 10% Requisition ID: R394030 #J-18808-Ljbffr Merck