Associate Principal Scientist, Biologics Analytical Research & Development

Merck's Biologics Analytical Research & Development department seeks an Associate Principal Scientist to develop and qualify analytical methods for complex therapeutic proteins. The role combines laboratory work with scientific leadership, requiring expertise in separations science, chromatography, and assay development to support drug substance and product development.

Responsibilities

• Develop, qualify, implement, and troubleshoot analytical methods for monoclonal and complex therapeutic proteins
• Create new assay platforms and benchmark current techniques against industry standards
• Design experiments and lead technical interpretation of data for assay development
• Author and review technical reports, regulatory filing sections, and scientific publications
• Provide scientific leadership and mentor technical personnel on analytical projects

Requirements

• B.S. in Chemistry, Biochemistry, Engineering, or related field with 12 years experience; or Master's with 8 years; or Ph.D. with 4 years
• Extensive experience with UPLC/HPLC analysis of biologics (SEC, RP, IEX chromatography)
• Strong background in process and impurity-related residual assay development using molecular biology and immunoassay techniques
• Sound understanding of Critical Quality Attributes, Quality by Design, Design of Experiments, data analysis, and statistics
• Ability to design, execute, and direct development and qualification of release, characterization, and stability assays
• Experience with assay qualification, validation, and transfer to GLP or regulated laboratory environments
• Excellent written and oral communication skills with proven cross-functional collaboration in academic or industrial settings

Compensation: $142,400.00 - $224,100.00 base