Principal Scientist, Large Molecule Analytical
Merck
August 20, 2026
On-site
Rahway, NJ
Clinical Research and Development
Responsibilities:
- Define analytical strategy and lead a team of scientists solving complex analytical problems at the biology/chemistry/lab informatics interface to enable development of biologics APIs.
- Work closely with the group Director; lead projects and contribute to group/departmental strategy.
- Mentor and develop scientific talent; foster matrix management and peer-to-peer coaching.
- Deliver impactful solutions under aggressive timelines; enable cross-functional collaboration and successful assay transfer.
- Design, execute, and/or direct development and qualification of release, characterization, and stability assays for clinical trial and product/process development.
- Author/review internal technical reports and contribute to regulatory filings (e.g., IND, BLA) and external publications.
Qualifications:
- Education: Ph.D. in analytical chemistry/biochemistry (8+ years pharma industry), or M.S. (10+ years), or B.S. (14+ years).
Required Experience/Skills:
- Extensive biologics analysis experience (e.g., SEC, IEX, CE).
- Process/impurity-related residual assay development using molecular biology and immunoassay.
- Analytical control strategy development and execution.
- Analytical Methodologies; strong CQAs/QbD/DOE knowledge; data analysis/statistics for specifications.
- Strong oral/written communication; ability to work independently and cross-functionally.
- Plan assay optimization and documentation to meet deadlines.
- Strong record of publication/external presentations.
Preferred Experience/Skills:
- Protein degradation mechanisms; complex glycan analysis and MoA links.
- Assay qualification/validation/transfer to GxP/regulated environments (ICH Q2, USP).
- Biologic modality experience (mAb, ADC, fusion protein) and ADC method development.
- High-throughput, data-rich experimentation.
Application:
- Apply at https://jobs.merck.com/us/en (deadline listed on posting).
- Define analytical strategy and lead a team of scientists solving complex analytical problems at the biology/chemistry/lab informatics interface to enable development of biologics APIs.
- Work closely with the group Director; lead projects and contribute to group/departmental strategy.
- Mentor and develop scientific talent; foster matrix management and peer-to-peer coaching.
- Deliver impactful solutions under aggressive timelines; enable cross-functional collaboration and successful assay transfer.
- Design, execute, and/or direct development and qualification of release, characterization, and stability assays for clinical trial and product/process development.
- Author/review internal technical reports and contribute to regulatory filings (e.g., IND, BLA) and external publications.
Qualifications:
- Education: Ph.D. in analytical chemistry/biochemistry (8+ years pharma industry), or M.S. (10+ years), or B.S. (14+ years).
Required Experience/Skills:
- Extensive biologics analysis experience (e.g., SEC, IEX, CE).
- Process/impurity-related residual assay development using molecular biology and immunoassay.
- Analytical control strategy development and execution.
- Analytical Methodologies; strong CQAs/QbD/DOE knowledge; data analysis/statistics for specifications.
- Strong oral/written communication; ability to work independently and cross-functionally.
- Plan assay optimization and documentation to meet deadlines.
- Strong record of publication/external presentations.
Preferred Experience/Skills:
- Protein degradation mechanisms; complex glycan analysis and MoA links.
- Assay qualification/validation/transfer to GxP/regulated environments (ICH Q2, USP).
- Biologic modality experience (mAb, ADC, fusion protein) and ADC method development.
- High-throughput, data-rich experimentation.
Application:
- Apply at https://jobs.merck.com/us/en (deadline listed on posting).