Program Lead - Method Remediation (Animal Health)

Merck•Millsboro, DE

10d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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.

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.