Associate Principal Scientist, Biologics Analytical R&D
Merck
June 29, 2026
On-site
Rahway, NJ
Clinical Research and Development
Role: Associate Principal Scientist (Biologics Analytical Research & Development), laboratory-based analytical R&D at Rahway, NJ.
Responsibilities:
- Develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal proteins/complex therapeutic proteins.
- Develop new assay platforms; benchmark analytical approaches to industry standards.
- Provide technical leadership for design of experiments (DoE) and data interpretation.
- Lead method bridging, comparability, and specification setting (from protocol to final report).
- Develop release/stability and characterization methods for clinical trial material and product/process development per ICH Q2(R2) through method qualification.
- Author/review SOPs, technical reports, publications, and regulatory filing sections (e.g., IND, BLA); matrix management and peer coaching.
Qualifications:
- Education: BS in Chemistry/Biochemistry/Engineering/Pharmaceutical Sciences or related with 10+ yrs; MS with 7+ yrs; PhD with 3+ yrs relevant experience.
Required experience/skills:
- Separation sciences with chromatography (SEC, RP, IEX, HILIC) and/or capillary electrophoresis (CE-SDS, iCIEF).
- Residual impurity assay development using molecular biology and immunoassay techniques (ELISA, qPCR, etc.).
- Excellent oral/written communication; work independently and cross-functionally.
Preferred:
- DoE/statistical analysis (JMP, MiniTab, FusionAE); broad assay knowledge (charge/size variants, glycans, purity/impurity).
- Protein degradation mechanisms; assay qualification/validation/transfer in GLP/regulated settings (ICH Q2, USP).
- Represent analytical functional area; experience with modalities (mAb, ADC, fusion proteins); data analytics.
Compensation/benefits (if applicable):
- Salary range: $142,400–$224,100; annual bonus/long-term incentive (if applicable); comprehensive medical/dental/vision, retirement (401(k)), paid time off.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is listed on the posting. Job posting end date: 07/14/2026.
Responsibilities:
- Develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal proteins/complex therapeutic proteins.
- Develop new assay platforms; benchmark analytical approaches to industry standards.
- Provide technical leadership for design of experiments (DoE) and data interpretation.
- Lead method bridging, comparability, and specification setting (from protocol to final report).
- Develop release/stability and characterization methods for clinical trial material and product/process development per ICH Q2(R2) through method qualification.
- Author/review SOPs, technical reports, publications, and regulatory filing sections (e.g., IND, BLA); matrix management and peer coaching.
Qualifications:
- Education: BS in Chemistry/Biochemistry/Engineering/Pharmaceutical Sciences or related with 10+ yrs; MS with 7+ yrs; PhD with 3+ yrs relevant experience.
Required experience/skills:
- Separation sciences with chromatography (SEC, RP, IEX, HILIC) and/or capillary electrophoresis (CE-SDS, iCIEF).
- Residual impurity assay development using molecular biology and immunoassay techniques (ELISA, qPCR, etc.).
- Excellent oral/written communication; work independently and cross-functionally.
Preferred:
- DoE/statistical analysis (JMP, MiniTab, FusionAE); broad assay knowledge (charge/size variants, glycans, purity/impurity).
- Protein degradation mechanisms; assay qualification/validation/transfer in GLP/regulated settings (ICH Q2, USP).
- Represent analytical functional area; experience with modalities (mAb, ADC, fusion proteins); data analytics.
Compensation/benefits (if applicable):
- Salary range: $142,400–$224,100; annual bonus/long-term incentive (if applicable); comprehensive medical/dental/vision, retirement (401(k)), paid time off.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is listed on the posting. Job posting end date: 07/14/2026.