Senior Scientist, Analytical R&D
Merck
June 30, 2026
On-site
Rahway, NJ
Clinical Research and Development
Senior Scientist, Biologics Analytical Research & Development (Rahway, NJ)
Responsibilities:
- Solve complex analytical problems at the interface of biology, chemistry, and lab informatics to enable development of biologics drug substances and drug products.
- Develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal proteins and other complex therapeutic proteins.
- Design and execute methods for release, characterization, and stability testing for clinical trial material and to support product/process development.
- Optimize assays, plan documentation, and meet program deadlines.
- Author/review internal technical reports, regulatory filing sections (e.g., IND, BLA), and external scientific publications.
Qualifications:
- Ph.D. in analytical chemistry/biochemistry (or related), or M.S. with 5+ years pharmaceutical industry experience, or B.S. with 8+ years pharmaceutical industry experience.
Required experience/skills:
- Separations science background; extensive UPLC/HPLC biologics analysis (SEC, RP, IEX) and CE techniques.
- Process/impurity-related residual assay development.
- Analytical method development; Critical Quality Attributes/QbD/DOE, data analysis/statistics for specifications.
- Strong oral/written communication; independent assay development and cross-functional assay transfer.
- Demonstrated scientific ability via publications and conference presentations.
- Ability to deliver complex objectives under aggressive timelines.
Preferred:
- Assay qualification/validation/transfer to GLP/regulated environments (ICH Q2, USP).
- Represent analytical functional area on project teams.
- Protein structure/degradation pathways; mass spectrometry.
- Molecular biology (PCR, DNA extraction) and immunoassay (ELISA, gel electrophoresis).
- Experience with mAb, ADC, fusion proteins.
Skills (role-specific keywords): Analytical method development, assay development, bioanalytical analysis, chromatographic techniques, immunoassays, immunoprecipitation, PAT, therapeutic proteins, UPLC.
Benefits:
- Comprehensive benefits package including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
Responsibilities:
- Solve complex analytical problems at the interface of biology, chemistry, and lab informatics to enable development of biologics drug substances and drug products.
- Develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal proteins and other complex therapeutic proteins.
- Design and execute methods for release, characterization, and stability testing for clinical trial material and to support product/process development.
- Optimize assays, plan documentation, and meet program deadlines.
- Author/review internal technical reports, regulatory filing sections (e.g., IND, BLA), and external scientific publications.
Qualifications:
- Ph.D. in analytical chemistry/biochemistry (or related), or M.S. with 5+ years pharmaceutical industry experience, or B.S. with 8+ years pharmaceutical industry experience.
Required experience/skills:
- Separations science background; extensive UPLC/HPLC biologics analysis (SEC, RP, IEX) and CE techniques.
- Process/impurity-related residual assay development.
- Analytical method development; Critical Quality Attributes/QbD/DOE, data analysis/statistics for specifications.
- Strong oral/written communication; independent assay development and cross-functional assay transfer.
- Demonstrated scientific ability via publications and conference presentations.
- Ability to deliver complex objectives under aggressive timelines.
Preferred:
- Assay qualification/validation/transfer to GLP/regulated environments (ICH Q2, USP).
- Represent analytical functional area on project teams.
- Protein structure/degradation pathways; mass spectrometry.
- Molecular biology (PCR, DNA extraction) and immunoassay (ELISA, gel electrophoresis).
- Experience with mAb, ADC, fusion proteins.
Skills (role-specific keywords): Analytical method development, assay development, bioanalytical analysis, chromatographic techniques, immunoassays, immunoprecipitation, PAT, therapeutic proteins, UPLC.
Benefits:
- Comprehensive benefits package including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Application deadline is stated on the posting.