Senior Scientist - Localization Analytical Lead

Senior Scientist – Localization Analytical Lead

The Global Quality‑Large Molecule Analytical Sciences (GQ‑LMAS) team leads the global analytical technical oversight of late‑stage pipeline programs through commercialization and launch as well as product lifecycle management support for Large Molecules (Vaccines and Biologics) and Cross‑Modality Compounds. The Localization Analytical Lead provides strategic and technical leadership for analytical validation, method transfer and lifecycle management to support technology transfer and localization of biologics/vaccines at partner sites.

This role ensures analytical readiness, regulatory compliance, and successful transfer of methods aligned with global standards.

• 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.
• Develop short and long‑term strategies for sustainability in BCR inventory and antisera generation needed to support testing at external partner laboratories and connect BCR performance with assay performance.
• 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.

• Successful on‑time analytical method transfers.
• Regulatory approval support for localized products.
• Improvement in partner site analytical capability and performance.
• Minimal transfer‑related deviations and robust assay performance at receiving sites.

• Bachelor’s Degree (BA/BS) in biology, chemistry, biochemistry, or related science with six (6) years of relevant industry knowledge in analytical testing, development, transfer, and/or validation; OR Master’s Degree (MA/MS) with four (4) years of relevant industry knowledge; OR PhD with two (2) years of relevant industry knowledge.

• Deep understanding of GMP, data integrity, and cGMP standards.
• Strong leadership and stakeholder management skills.
• Excellent problem‑solving and communication abilities.
• Ability to work across cultures and global teams.

• Technical
  
  Skills:
  
  
  • 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.
• Soft Skills:
  • Strong leadership and stakeholder management skills.
  • Excellent problem‑solving and communication abilities.
  • Ability to work across cultures and global teams.

Up to 25–40% travel.

US and Puerto Rico residents only.

Salary range: $ – $. Eligible for annual bonus and long‑term incentives, if applicable. Comprehensive benefits package includes medical, dental, vision, healthcare and other insurance benefits for employee and family, retirement benefits including 401(k), paid holidays, vacation, compassionate and sick days.

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: EEOC Know Your Rights, EEOC GINA Supplement.