Program Lead - Method Remediation (Animal Health)
Merck
6 months ago
Remote friendly (Millsboro, DE)
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 a subject matter expert and senior troubleshooter; coach and support technical team members through remediation execution.
- Author method remediation protocols, validation reports, and USDA regulatory submissions; update internal and regulatory procedures as required.
- Lead post‑remediation activities, including subject matter export role in change control assessments.
- 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, laboratory operations) and implement remediation or training plans.
- 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 related biological science.
- Required experience/skills:
- 7+ years bench-level QC method development, validation, and troubleshooting in vitro bioassays for complex animal health vaccines; proven ability writing protocols and validation reports.
- 5+ years bioassay data analysis, trending, and interpretation.
- Familiarity with USDA regulations.
- 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) and proven ability to troubleshoot across multiple platforms.
- Ability to lead cross-functional collaborations (Quality, Manufacturing, Regulatory, R&D) and manage multi-site projects.
- Strong technical writing; excellent communication and presentation skills.
Preferred Experience/Skills
- 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 and 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 through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
- 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 a subject matter expert and senior troubleshooter; coach and support technical team members through remediation execution.
- Author method remediation protocols, validation reports, and USDA regulatory submissions; update internal and regulatory procedures as required.
- Lead post‑remediation activities, including subject matter export role in change control assessments.
- 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, laboratory operations) and implement remediation or training plans.
- 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 related biological science.
- Required experience/skills:
- 7+ years bench-level QC method development, validation, and troubleshooting in vitro bioassays for complex animal health vaccines; proven ability writing protocols and validation reports.
- 5+ years bioassay data analysis, trending, and interpretation.
- Familiarity with USDA regulations.
- 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) and proven ability to troubleshoot across multiple platforms.
- Ability to lead cross-functional collaborations (Quality, Manufacturing, Regulatory, R&D) and manage multi-site projects.
- Strong technical writing; excellent communication and presentation skills.
Preferred Experience/Skills
- 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 and 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 through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee). Application deadline is stated on the posting.