Senior Scientist - Localization Analytical Lead

Senior Scientist - Localization Analytical Lead Senior Scientist – Localization Analytical Lead in the Global Quality – Large Molecule Analytical Sciences (GQ‑LMAS) team. This role provides strategic and technical leadership for analytical validation, method transfer, and lifecycle management to support technology transfer and localization of biologics and vaccines at partner sites. Key duties include ensuring analytical readiness, regulatory compliance, and effective communication with cross‑divisional teams. Key Responsibilities Define and execute the analytical strategy to support localization, tech transfer, and commercial readiness. Serve as the primary point of contact for drug substance and drug product testing. Lead analytical method transfer activities to external partners and ensure receiving sites are prepared with appropriate equipment, training, and systems. Troubleshoot transfer challenges, implement mitigation strategies, and collaborate closely with site teams to ensure successful method adoption and performance. Partner with the BCR hub to develop short‑ and long‑term strategies for sustainability in BCR inventory and antisera generation needed to support testing at external partner laboratories. Ensure all analytical activities adhere to cGMP and data integrity standards and partner with QA to address deviations, investigations, and CAPAs related to analytical work. Support regulatory filings, RTQs for local approvals, PAI readiness, and audit observations. Required Qualifications Bachelor's Degree (BA/BS) in biology, chemistry, biochemistry, or related science with six (6) years of relevant industry experience in analytical testing, development, transfer, and/or validation. Master's Degree (MA/MS) in the same fields with four (4) years of relevant industry experience in analytical testing, development, transfer, and/or validation. PhD in biology, chemistry, biochemistry, or related science with two (2) years of relevant industry experience in analytical testing, development, transfer, and/or validation. Preferred Experience Expertise in analytical techniques (HPLC/UPLC, ELISA, PCR, cell‑based assays, etc.). Deep knowledge of method validation and regulatory expectations (ICH Q2, Q14, WHO guidelines). Experience with comparability and transfer protocols. Strong leadership and stakeholder management skills. Excellent problem‑solving and communication abilities. Ability to work across cultures and global teams. Adaptability, decision making, detail orientation, GMP knowledge, quality standards, team problem solving, and technical transfer. Travel Requirements Up to 25‑40% travel. Compensation & Benefits Salary Range: $106,200.00 – $167,200.00. Eligible for annual bonus and long‑term incentive, if applicable. Benefits include 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. Equal Employment Opportunity Statement We are an equal opportunity employer and a federal contractor. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. We 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. For more information about your rights, including under California, Colorado, and other U.S. State Acts, please visit the EEOC resources available online. #J-18808-Ljbffr Merck & Co.