Program Lead - Method Remediation (Animal Health)
Merck
6 months ago
Remote friendly (Omaha, NE)
United States
Operations
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.
- Serve as 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.
- 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 and implement remediation or training plans to ensure successful transfer and ongoing performance.
- Provide hands-on training during transfers and oversee transfer documentation (protocols, validation reports, supporting documents).
- Lead post-transfer monitoring and hypercare support to confirm method robustness and 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: Bachelor’s degree in Biology, Genetics, Immunology, Microbiology, Virology, or a related biological science.
- Experience/Skills (Required):
- Minimum 7 years bench-level Quality Control method development, validation and troubleshooting for in vitro bioassays for complex animal health vaccines; strong history writing protocols and validation reports.
- Minimum 5 years bioassay data analysis, trending and interpretation.
- Familiarity with USDA regulations and requirements.
- Project management experience delivering analytical method development, remediation and transfer projects, including reactive investigations.
- Subject matter expertise in at least one bioassay platform (e.g., ELISA, virus titration, HA/HI) with proven troubleshooting across multiple platforms.
- Proven ability to lead cross-functional collaborations across Quality, Manufacturing, Regulatory and R&D; manage multi-site projects.
- Strong technical writing; prepare protocols, validation reports and regulatory documentation for USDA review.
- Excellent communication/presentation skills to senior leadership.
- Experience/Skills (Preferred):
- Expertise in bioassay experimental design and statistical interpretation.
- Familiarity with analytical technologies (e.g., digital imagers, liquid handlers).
- People management experience developing technical talent.
- Track record presenting data/recommendations to cross-functional stakeholders.
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
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
- Requisition ID: R392782
- 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.
- Serve as 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.
- 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 and implement remediation or training plans to ensure successful transfer and ongoing performance.
- Provide hands-on training during transfers and oversee transfer documentation (protocols, validation reports, supporting documents).
- Lead post-transfer monitoring and hypercare support to confirm method robustness and 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: Bachelor’s degree in Biology, Genetics, Immunology, Microbiology, Virology, or a related biological science.
- Experience/Skills (Required):
- Minimum 7 years bench-level Quality Control method development, validation and troubleshooting for in vitro bioassays for complex animal health vaccines; strong history writing protocols and validation reports.
- Minimum 5 years bioassay data analysis, trending and interpretation.
- Familiarity with USDA regulations and requirements.
- Project management experience delivering analytical method development, remediation and transfer projects, including reactive investigations.
- Subject matter expertise in at least one bioassay platform (e.g., ELISA, virus titration, HA/HI) with proven troubleshooting across multiple platforms.
- Proven ability to lead cross-functional collaborations across Quality, Manufacturing, Regulatory and R&D; manage multi-site projects.
- Strong technical writing; prepare protocols, validation reports and regulatory documentation for USDA review.
- Excellent communication/presentation skills to senior leadership.
- Experience/Skills (Preferred):
- Expertise in bioassay experimental design and statistical interpretation.
- Familiarity with analytical technologies (e.g., digital imagers, liquid handlers).
- People management experience developing technical talent.
- Track record presenting data/recommendations to cross-functional stakeholders.
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
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
- Requisition ID: R392782