Associate Principal Scientist, Analytical R&D

Overview The Associate Principal Scientist position will support our Live Virus Vaccines (LVV) franchise. This broad role includes working with Analytical Product Leaders (APLs) to develop and implement analytical strategies, focusing on the transition from clinical to commercial stages; driving method alignment and supporting consistent executional excellence across multiple testing laboratories; developing and maintaining a robust assay monitoring effort and supporting method procedure life cycle management, including automation and modernization as applicable. The role is technical and requires demonstrated expertise in vaccine analytics, effective collaboration with external contract providers, research laboratories, supply chain, site and global Quality, and CMC‑Regulatory teams. It will be based in West Point, PA and is a site‑based position. Responsibilities Work with APLs to develop and implement the commercialization analytical strategy across testing nodes. Participate in significant investigations across the viral vaccines franchise. Provide Subject Method Expertise to QC analysts and supervisors, assess impact of proposed changes and deviations. In partnership with the AWG and network QC labs, support definition of opportunities for improvement/investment in equipment and technology required to drive assay modernization and implement harmonized network solutions, including working with our Digital manufacturing Division and LMAS team for assay digitization with harmonized data capture. In partnership with the BCR hub, develop short and mid‑term strategy for sustainability in BCR inventory and antisera generation needed to support all testing laboratories in the network and connect BCR performance with assay performance. Provide SME support to APLC gap assessments of key methods to drive improved and sustainable robustness. Ensure method performance data are presented, discussed and actions developed at analytical working group meetings as appropriate. Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) to ensure uninterrupted supply. Escalate key assay challenges to management in a timely and concise manner. Support RTQs, PAI readiness and audit observations. Educational and Experience Requirements Bachelor’s Degree (BA/BS) with a concentration in sciences with six (6) years of experience working in analytical testing, development, transfer, and/or validation. Master’s Degree (MA/MS) with a concentration in sciences with four (4) years of experience working in analytical testing, development, transfer, and/or validation. PhD with a concentration in sciences with two (2) years of experience working in analytical testing, development, transfer, and/or validation. Required Experience and Skills Demonstrated experience with analytics for commercial vaccine and/or microbiological products. Effective communication and teamwork. Experience with large molecule GMP testing, including drug substance and drug product stability and release testing. Experience with analytical comparability. Experience leading a cross‑functional team. Strong technical expertise in general large molecule analytical laboratory operations, equipment, and techniques. Preferred Experience and Skills Continuous improvement or Project Management training. Writing or review of technical documents, preferably including regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA). Experience with large molecule analytical transfers. Experience with commercial product analytical method changes. Experience with assay monitoring and trending. Benefits We offer a comprehensive package of benefits, including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. Salary Salary range: $142,400.00 - $224,100.00. Bonus and long‑term incentive may be eligible. 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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC resources. #J-18808-Ljbffr Merck & Co.