Associate Principal Scientist
Merck
July 02, 2026
On-site
West Point, PA
Clinical Research and Development
Key Functions
- Serve as a subject matter expert in vaccine bioassays, providing support and training for LMAS and QC laboratories globally.
- Contribute to QC investigations with technical troubleshooting skills; assist in developing/implementing CAPAs.
- Contribute to Assay Procedure Lifecycle Management for vaccine ELISAs and similar assays (method optimization/modernization, performance monitoring, and workflow optimization).
- Author or review analytical procedures, method transfer protocols and reports, technical reports, experimental designs, and regulatory submission documents.
- Provide technical input during inspections and audits.
- Support development of digital methods and deployment to global QC sites.
Minimum Education and Experience
- BS/BA in sciences + 8 years in analytical testing, development, transfer, and/or validation; OR
- MS/MA in sciences + 6 years; OR
- PhD in sciences + 3 years.
Required
- Expertise with bioassays: ELISA immunoassays and/or other binding-based assay technologies for large molecules.
- Experience in a cGMP laboratory (vaccines/biologics) with immunochemical analytical methods.
- Manage project timelines and deliverables.
- Author/review technical documents.
- Work independently and in cross-functional teams.
- Strong communication (oral/written), interpersonal, organizational, and project management skills.
- Identify and communicate risks.
- Experience with drug substance/product release, stability, and extended characterization testing for vaccines/biologics.
Preferred
- Late-stage method development, validation, transfer, and troubleshooting.
- Digital methods/templates (e.g., SoftMax Pro).
- Quality and regulatory requirements; working knowledge of CMC filing requirements; experience with CMOs and CROs.
- Serve as a subject matter expert in vaccine bioassays, providing support and training for LMAS and QC laboratories globally.
- Contribute to QC investigations with technical troubleshooting skills; assist in developing/implementing CAPAs.
- Contribute to Assay Procedure Lifecycle Management for vaccine ELISAs and similar assays (method optimization/modernization, performance monitoring, and workflow optimization).
- Author or review analytical procedures, method transfer protocols and reports, technical reports, experimental designs, and regulatory submission documents.
- Provide technical input during inspections and audits.
- Support development of digital methods and deployment to global QC sites.
Minimum Education and Experience
- BS/BA in sciences + 8 years in analytical testing, development, transfer, and/or validation; OR
- MS/MA in sciences + 6 years; OR
- PhD in sciences + 3 years.
Required
- Expertise with bioassays: ELISA immunoassays and/or other binding-based assay technologies for large molecules.
- Experience in a cGMP laboratory (vaccines/biologics) with immunochemical analytical methods.
- Manage project timelines and deliverables.
- Author/review technical documents.
- Work independently and in cross-functional teams.
- Strong communication (oral/written), interpersonal, organizational, and project management skills.
- Identify and communicate risks.
- Experience with drug substance/product release, stability, and extended characterization testing for vaccines/biologics.
Preferred
- Late-stage method development, validation, transfer, and troubleshooting.
- Digital methods/templates (e.g., SoftMax Pro).
- Quality and regulatory requirements; working knowledge of CMC filing requirements; experience with CMOs and CROs.