Senior Scientist, Biologics Analytical R&d

Merck Merck · Pharma · NJ

Senior Scientist in Biologics Analytical R&D at Merck, focused on developing, qualifying, and troubleshooting analytical methods for therapeutic proteins. Requires a strong background in separations science (UPLC/HPLC, CE) and experience with assay development for release, characterization, and stability testing. The role involves scientific leadership, collaboration, and authoring technical reports and regulatory filings.

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.
  5. Experience leading small groups of technical personnel and analytical projects

Skills

Required

  • Adaptability
  • Analytical Chemistry
  • Analytical Method Development
  • Antibody Drug Conjugates (ADC)
  • Assay Development
  • Capillary Electrophoresis (CE)
  • Chromatographic Techniques
  • Cross-Functional Teamwork
  • DNA Extractions
  • External Collaboration
  • High-Performance Liquid Chromatography (HPLC)
  • Molecular Biology
  • Process Analytical Technology (PAT)
  • Protein Analysis
  • Size Exclusion Chromatography (SEC)
  • Teamwork
  • Therapeutic Proteins
  • Ultra Performance Liquid Chromatography (UPLC)

Nice to have

  • qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP<1033>
  • representing analytical functional area on project teams
  • Strong knowledge of protein structure and degradation pathways
  • Mass spectrometry for large molecules
  • Molecular biology (PCR, DNA extraction) and immunoassay (ELISA, gel electrophoresis) techniques
  • analysis of various Biologic modalities (e.g., 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
  • A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays.
  • Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
  • Demonstrated scientific ability through publications and presentations in scientific conferences.