Sr. Scientist, Analytical R&d

Merck Merck · Pharma · NJ

Senior Scientist in Biologics Analytical Research & Development at Merck, focused on solving complex analytical problems for drug substance and product development. Responsibilities include method development, qualification, implementation, troubleshooting, and transfer for monoclonal proteins and other complex therapeutic proteins. Requires strong background in separations science (UPLC/HPLC, CE), assay development, and understanding of Critical Quality Attributes. Role involves authoring technical reports and regulatory filings, with a strong emphasis on scientific leadership and collaboration.

What you'd actually do

  1. development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins
  2. design, execute and development of methods for release, characterization, and stability testing of clinical trial material and in support of product and process development
  3. Plan assay optimization and documentation to meet program deadlines
  4. Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications
  5. Demonstrated scientific ability through publications and presentations in scientific conferences

Skills

Required

  • Analytical Chemistry
  • Analytical Method Development
  • Bioanalytical Analysis
  • Biochemical Assays
  • Capillary Electrophoresis (CE)
  • Chromatographic Techniques
  • Enzyme Linked Immunosorbent Assay (ELISA)
  • Therapeutic Proteins
  • separations science
  • UPLC/HPLC analysis of biologics
  • SEC
  • RP
  • IEX
  • CE techniques
  • process- or impurity-related residual assay development
  • Analytical Methodologies
  • Critical Quality Attributes
  • QbD
  • DOE principles
  • data analysis
  • statistics
  • setting specifications
  • release testing
  • characterization testing
  • stability testing
  • clinical trial material
  • product and process development
  • assay optimization
  • documentation
  • program deadlines
  • internal technical reports
  • regulatory filings
  • IND
  • BLA
  • external scientific publications
  • aggressive timelines
  • rapidly changing environment
  • publications
  • presentations
  • scientific conferences

Nice to have

  • qualification
  • validation
  • transfer of assays to a GLP or regulated laboratory environment
  • ICH Q2
  • USP <1033>
  • representing analytical functional area on project teams
  • protein structure
  • degradation pathways
  • Mass spectrometry for large molecules
  • Molecular biology
  • PCR
  • DNA extraction
  • immunoassay
  • gel electrophoresis
  • analysis of various Biologic modalities
  • mAb
  • antibody-drug conjugate
  • fusion protein

What the JD emphasized

  • Ph.D. in analytical chemistry/biochemistry or related field or M.S. with a minimum of 5 years of experience in the Pharmaceutical Industry or B.S. with a minimum of 8 years of experience in the Pharmaceutical Industry
  • Strong background and experience in separations science
  • Extensive experience with UPLC/HPLC analysis of biologics (e.g., SEC, RP, IEX) and CE techniques
  • Experience in process- or impurity-related residual assay development
  • Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications
  • Ability to design, execute and development of methods for release, characterization, and stability testing of clinical trial material and in support of product and process development
  • Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment
  • Demonstrated scientific ability through publications and presentations in scientific conferences