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

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.

• 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:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

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 if you need an accommodation during the application or hiring process.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available 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. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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