Sr. Scientist, Analytical R&d

Merck Merck · Pharma · NJ

Senior Scientist in Merck's Biologics Analytical Research & Development department focused on solving complex analytical problems at the interface of biology, chemistry, and lab informatics for drug 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/QbD/DOE principles. Experience with regulatory filings and publications is expected.

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. Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.
  4. Plan assay optimization and documentation to meet program deadlines.

Skills

Required

  • Analytical Chemistry
  • Analytical Method Development
  • Bioanalytical Analysis
  • Biochemical Assays
  • Capillary Electrophoresis (CE)
  • Chromatographic Techniques
  • Enzyme Linked Immunosorbent Assay (ELISA)
  • Therapeutic Proteins
  • UPLC/HPLC analysis of biologics
  • SEC
  • RP
  • IEX
  • Critical Quality Attributes/QbD/DOE principles
  • data analysis and statistics
  • release testing
  • characterization testing
  • stability testing
  • regulatory filings (IND, BLA)
  • scientific publications

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 (ELISA, 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
  • Demonstrated scientific ability through publications and presentations in scientific conferences.