Associate Principal Scientist

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.

• BS/BA in sciences + 8 years in analytical testing, development, transfer, and/or validation;
• MS/MA in sciences + 6 years;
• PhD in sciences + 3 years.

• 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.

• Late‑stage method development, validation, transfer, and troubleshooting.
• Digital methods/templates (e.g., Soft Max Pro).
• Quality and regulatory requirements; working knowledge of CMC filing requirements; experience with CMOs and CROs.