Senior Scientist - Localization Analytical Lead

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.
• In partnership with the BCR hub, develop short and long-term strategies for sustainability in BCR inventory and antisera generation needed to support testing at external partner's 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.
• Required Qualifications:
• Bachelor's Degree (BA/BS) with a concentration in biology, chemistry, biochemistry, or related science with six (6) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation; OR
• Master's Degree (MA/MS) with a concentration in biology, chemistry, biochemistry, or related science with four (4) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation; OR
• PhD with a concentration in biology, chemistry, biochemistry, or related science with two (2) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation
• Travel Requirements:
• Up to 25-40% travel
• Preferred Experience :
• 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.
• Key Success Metrics:
• 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.
• Required Skills:
• Adaptability, Analytical Method Development, Decision Making, Detail-Oriented, Good Manufacturing Practices (GMP), Quality Standards, Team Problem Solving, Technical Transfer
• Preferred Skills:
• Current Employees apply HERE
• Current Contingent Workers apply HERE
• US and Puerto Rico Residents Only:
• Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Benefits

Additional Information

Job Description 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 (i.e. Antibody-Drug Conjugates). This team is highly motivated, fast-paced and focused on a robust analytical testing network that enables our company's strategic priorities to deliver life-changing products through pipeline acceleration and uninterrupted supply of commercial products. This position plays a critical role in expanding global access to essential biologics and vaccines by enabling high-quality local manufacturing through strong analytical foundations. The Localization Analytical Lead will be responsible for providing 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 will ensure analytical readiness, regulatory compliance, and successful transfer of methods aligned with global standards. This role involves effective communication and teamwork with external partners and cross-divisional collaborations at local site and global levels. This position will also work directly with technical operations, quality, regulatory, analytical program leaders and method subject matter experts on a regular basis

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