Job Description

As a Methods Specialist, you will be part of a world-class team, contributing directly to the production and testing of veterinary products that improve animal health and welfare globally.  You will collaborate closely with Quality Control, Manufacturing Operations, Bioprocess Technology Solutions, Regulatory Affairs, Statistics, and Analytical Technology Solutions across US sites to align priorities, expectations and deliverables.  Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence.  Because when it comes to animal health, no one sees it like we do.

Key Responsibilities:

• Support complex data analysis and trending to identify non-robust or out-of-specification methods.  Conduct biomaterials assessments, inventory reviews, and document gap analyses to define remediation actions.
• Perform bench-level remediation across multiple test platforms, including live bacterial and virus titration/identification and ELISA for complex multivalent vaccines and in-process materials, working under guidance from senior team members.
• Author method remediation protocols, validation reports, and regulatory submissions for USDA review and approval with oversight from senior staff; update internal and regulatory procedures as required.
• Support post-remediation activities such as change control assessments and verification of sustained method performance.
• Participate in or lead cross-functional teams for site-to-site analytical method transfers: establish transfer plans, assess site readiness, and manage timelines, risks and deliverables with support from senior team members.
• Perform gap assessments of site capabilities – technical expertise, instrumentation, and laboratory operations — and implement remediation or training plans to ensure successful transfer and ongoing performance.
• Provide hands-on training during transfers (technical execution, assay operation, instrumentation use) and oversee transfer documentation protocols, validation reports and supporting documents.
• Support or lead post-transfer monitoring and hypercare to confirm method robustness and to resolve residual issues.
• Use internal project management systems to track progress, manage risks and report metrics with guidance from senior team members.
• Present technical updates, findings and recommend risk mitigations at team and regional meetings as needed.

Education Minimum Requirement:

• Bachelor’s Degree in Biology, Genetics, Immunology, Microbiology, Virology, or a related biological science.

Required Experience and Skills:

• Minimum 4 years of bench-level experience with an emphasis on Quality Control in vitro bioassay development for complex animal health vaccines; experience writing protocols and validation reports.
• Minimum 4 years of bioassay data analysis, trending and interpretation.
• Demonstrated familiarity with USDA regulations and requirements.
• Developing subject matter expertise in at least one bioassay platform (e.g. ELISA, virus titration, HA/HI) and proven ability to troubleshoot across multiple platforms.
• Developing skill sets in bioassay data analysis, trending and interpretation.
• Strong technical writing skills with experience preparing validation protocols and reports, and regulatory documentation for USDA review.
• Effective communication and presentation skills.

Preferred Experience and Skills:

• Experience in bioassay experimental design and statistical interpretation.
• Experience designing methods to meet USDA regulatory expectations.
• Familiarity with analytical technologies such as imagers and liquid handlers.
• Experience presenting technical results to cross-functional stakeholders

GAHM-ILC

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. 

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Relocation:

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Travel Requirements:

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