Associate Principal Scientist, Analytical R&D

Job Overview Associate Principal Scientist – Live Virus Vaccines (LVV) franchise. The role focuses on supporting the transition from clinical to commercial stages, driving method alignment across laboratories, maintaining assay monitoring, and modernizing processes. Responsibilities Work with Analytical Product Leaders (APLs) to develop and implement the commercialization analytical strategy across testing nodes. Participate in investigations across the viral vaccines franchise. Provide subject method expertise to QC analysts and supervisors, assessing impacts of proposed changes and deviations. Collaborate with the AWG and network QC labs to identify opportunities for equipment and technology improvements and support assay modernization. Partner with the Digital Manufacturing Division and LMAS team to digitize assay data capture. Develop short- and mid-term strategies for BCR inventory and antisera generation with the BCR hub, linking BCR performance to assay performance. Support APLC gap assessments of key methods to drive sustainable robustness. Present and discuss method performance data at analytical working group meetings, developing action plans as needed. Collaborate across internal networks, external partners, international governments, and CMO/CROs to ensure uninterrupted supply. Escalate key assay challenges to management in a timely and concise manner. Support RTQs, PAI readiness, and audit observations. Minimum Education and Experience • Bachelor’s Degree in a scientific discipline with 6+ years of experience in analytical testing, development, transfer, and/or validation. 〈OR〉• Master’s Degree in a scientific discipline with 4+ years of experience in analytical testing, development, transfer, and/or validation. 〈OR〉• PhD in a scientific discipline with 2+ years of experience in analytical testing, development, transfer, and/or validation. Required Experience & 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 large molecule analytical laboratory operations, equipment, and techniques. Preferred Experience & Skills Continuous improvement or Project Management training. Writing or review of technical documents, including regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with agencies such as FDA, EMA, JNDA. Experience with large molecule analytical transfers. Experience with commercial product analytical method changes. Experience with assay monitoring and trending. Key Technical Skills Adaptability Analytical Method Development Assay Development Biological Assay Development Cell-Based Assays Chromatographic Techniques Cross-Functional Teamwork External Collaboration High Resolution Mass Spectrometry (HRMS) Liquid Chromatography-Mass Spectrometry (LC-MS) Mass Spectrometry Analysis Process Analytical Technology (PAT) Protein Analysis Teamwork Equal Employment Opportunity & Affinity Programs 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 any other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. Salary & Benefits Salary range: $142,400.00 - $224,100.00.Benefits include medical, dental, vision, and other insurance benefits for employees and families; retirement benefits, including a 401(k) plan; paid holidays, vacation, and compassionate and sick days. Location West Point, Pennsylvania – site‑based position. #J-18808-Ljbffr MSD Malaysia