Associate Principal Scientist, Biologics Analytical R&D
Merck
September 02, 2026
On-site
Rahway, NJ
Clinical Research and Development
Responsibilities:
- Develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal proteins and other complex therapeutic proteins.
- Create new assay platforms; benchmark approaches against industry standards.
- Provide technical leadership for design of experiments (DOE) and data interpretation.
- Lead method bridging/comparability/specification setting from protocol through final report.
- Develop release/stability/characterization methods for clinical trial and product/process development per ICH Q2(R2) through method qualification.
- Author/review SOPs, technical reports, publications, and relevant regulatory filing sections (e.g., IND, BLA).
Qualifications:
- Education: BS (10+ yrs), MS (7+ yrs), or PhD (3+ yrs) in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related field.
- Hands-on separation sciences (chromatography: SEC/RP/IEX/HILIC) and/or capillary electrophoresis (CE-SDS, iCIEF).
- Residual impurity assay development using molecular biology and immunoassays (e.g., ELISA, qPCR).
- Excellent oral/written communication; independent and cross-functional work.
- Matrix management and peer-to-peer coaching.
Preferred:
- DOE/statistical analysis (JMP/MiniTab/FusionAE), broad biologics assay knowledge (charge/size variants, glycans, purity/impurity), protein degradation understanding, assay qualification/validation/transfer to GLP/regulated environments (ICH Q2/USP).
- Experience representing analytical functional area; biologic modalities (mAb, ADC, fusion proteins); data analytics.
Application:
- Apply via https://jobs.merck.com/us/en. Application deadline is stated on the posting.
- Requisition ID: R404891.
- Develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal proteins and other complex therapeutic proteins.
- Create new assay platforms; benchmark approaches against industry standards.
- Provide technical leadership for design of experiments (DOE) and data interpretation.
- Lead method bridging/comparability/specification setting from protocol through final report.
- Develop release/stability/characterization methods for clinical trial and product/process development per ICH Q2(R2) through method qualification.
- Author/review SOPs, technical reports, publications, and relevant regulatory filing sections (e.g., IND, BLA).
Qualifications:
- Education: BS (10+ yrs), MS (7+ yrs), or PhD (3+ yrs) in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related field.
- Hands-on separation sciences (chromatography: SEC/RP/IEX/HILIC) and/or capillary electrophoresis (CE-SDS, iCIEF).
- Residual impurity assay development using molecular biology and immunoassays (e.g., ELISA, qPCR).
- Excellent oral/written communication; independent and cross-functional work.
- Matrix management and peer-to-peer coaching.
Preferred:
- DOE/statistical analysis (JMP/MiniTab/FusionAE), broad biologics assay knowledge (charge/size variants, glycans, purity/impurity), protein degradation understanding, assay qualification/validation/transfer to GLP/regulated environments (ICH Q2/USP).
- Experience representing analytical functional area; biologic modalities (mAb, ADC, fusion proteins); data analytics.
Application:
- Apply via https://jobs.merck.com/us/en. Application deadline is stated on the posting.
- Requisition ID: R404891.