Program Lead - Method Remediation (Animal Health)

Job Description

Join Us in Shaping the Future of Animal Health

The Program Lead – Method Remediation (Animal Health) will serve as a subject matter expert, coach and technical team lead driving remediation strategy, prioritizing projects, coordinating resources, and report portfolio status to senior stakeholders. The Program Lead 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.

Key Responsibilities:

• Lead 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.
• Provide technical leadership and perform bench-level remediation across multiple test platforms, including live bacterial and viral titration/identification and ELISA for complex multivalent vaccines and in‑process materials.
• Act as a subject matter expert and senior troubleshooter: coach and support technical team members through remediation execution.
• Author method remediation protocols, validation reports, and regulatory submissions for USDA review and approval; update internal and regulatory procedures as required.
• Lead post‑remediation activities, including subject matter export role in change control assessments.
• May guide biomaterials replacement and qualification activities as needed.
• Lead cross‑functional, site‑to‑site analytical method transfers: establish transfer plans, assess site readiness, and manage timelines, risks and deliverables.
• 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.
• Lead post‑transfer monitoring and hypercare support to confirm method robustness and to resolve residual issues.
• Use internal project management systems to track progress, manage risks and report metrics.
• Present project updates, technical findings and risk mitigation plans at local, regional and global forums.

Job Requirements:

Education Minimum Requirement:
Bachelor’s degree in Biology, Genetics, Immunology, Microbiology, Virology, or a related biological science.

Required Experience and Skills:

• Minimum 7 years of bench‑level Quality Control method development, validation and troubleshooting with emphasis on in vitro bioassays for complex animal health vaccines; strong history of writing protocols and validation reports.
• Minimum 5 years of experience in bioassay data analysis, trending and interpretation.
• Demonstrated familiarity with USDA regulations and requirements.
• Project management experience delivering analytical method development, remediation and transfer projects, including management of reactive investigations.
• Recognized subject matter expertise in at least one bioassay platform (e.g., ELISA, virus titration, HA/HI) and proven ability to troubleshoot across multiple platforms.
• Proven ability to lead cross‑functional collaborations across Quality, Manufacturing, Regulatory and R&D, and to manage projects across multiple sites.
• Strong technical writing skills with demonstrated experience preparing protocols, validation reports and regulatory documentation for USDA review.
• Excellent communication and presentation skills; comfortable presenting technical data and program status to senior leadership and other audiences.

Preferred Experience and Skills:

• Expertise in bioassay experimental design and statistical interpretation.
• Familiarity with analytical technologies (e.g., digital imagers, liquid handlers).
• People management experience and demonstrated ability to develop technical talent.

• Track record presenting data and recommendations to cross‑functional stakeholders at multiple organizational levels.

What We’re Looking For

We seek individuals who:

• Demonstrate execution excellence through effective problem-solving and critical thinking.
• Embrace an entrepreneurial mindset, taking initiative and ownership of their work.
• Adapt with agility and resilience in a dynamic, fast-paced environment.
• Uphold a safety-first, quality always mindset, prioritizing the well‑being of colleagues and the integrity of analytical methods.

Why Join Us?

• Be part of a transformative organization that will shape the future of animal health
• Work with a dynamic and experienced team
• Contribute to cutting-edge research and manufacturing of large-molecule vaccines and biologic products
• Help us meet growing global demand for our portfolio of animal health solutions

Required Skills:

BioAssay, Biologics, Driving Continuous Improvement, ELISA Test, Leadership, Manufacturing Quality Control, Process Improvements, Regulatory Compliance, Teamwork, Technical Problem-Solving, Titration Technique, USDA Regulations

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.

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​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$129,000.00 - $203,100.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/25/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.