Associate Principal Scientist, Biologics Analytical Research & Development
Merck
12 hours ago
On-site
Rahway, NJ
Clinical Research and Development
Role/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.
- Develop new assay platforms; benchmark techniques against industry standards.
- Provide technical leadership for design of experiments (DOE) and data interpretation.
- Lead assay optimization, documentation, and transfer to meet program deadlines.
- Author/review internal technical reports, regulatory filing sections (e.g., IND, BLA), and external scientific publications.
Qualifications:
- Education: BS (12 yrs relevant experience) or MS (8 yrs) or PhD (4 yrs) in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or related field.
Required Experience/Skills:
- Separations science; extensive UPLC/HPLC of biologics (SEC, RP, IEX).
- Residual/process/impurity assay development using molecular biology and immunoassay techniques.
- Analytical Methodologies; Critical Quality Attributes (CQAs), QbD, DOE principles; data analysis/statistics for specifications.
- Design/execute/direct development and qualification of release, characterization, and stability assays for clinical trial and product/process development.
- Strong oral/written communication; cross-functional assay transfer; accurate/efficient experiment documentation.
- Authoring/reviewing technical and regulatory documents; matrix management and peer coaching.
Preferred:
- Protein degradation mechanisms; regulated/GLP assay qualification/validation/transfer (ICH Q2, USP).
- Represent analytical function on project teams; complex glycan analysis; analysis across modalities (mAb, ADC, fusion proteins).
Skills (examples): Analytical/assay development; chromatographic techniques; HRMS/LC-MS; Process Analytical Technology (PAT); protein analysis; cross-functional teamwork.
Benefits (if applicable): Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application: Apply via https://jobs.merck.com/us/en (current employees via Workday Jobs Hub). Application deadline listed on the posting; job posting end date effective until 11:59:59 PM the day before 06/12/2026. Requisition ID: R399133.
- 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.
- Develop new assay platforms; benchmark techniques against industry standards.
- Provide technical leadership for design of experiments (DOE) and data interpretation.
- Lead assay optimization, documentation, and transfer to meet program deadlines.
- Author/review internal technical reports, regulatory filing sections (e.g., IND, BLA), and external scientific publications.
Qualifications:
- Education: BS (12 yrs relevant experience) or MS (8 yrs) or PhD (4 yrs) in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or related field.
Required Experience/Skills:
- Separations science; extensive UPLC/HPLC of biologics (SEC, RP, IEX).
- Residual/process/impurity assay development using molecular biology and immunoassay techniques.
- Analytical Methodologies; Critical Quality Attributes (CQAs), QbD, DOE principles; data analysis/statistics for specifications.
- Design/execute/direct development and qualification of release, characterization, and stability assays for clinical trial and product/process development.
- Strong oral/written communication; cross-functional assay transfer; accurate/efficient experiment documentation.
- Authoring/reviewing technical and regulatory documents; matrix management and peer coaching.
Preferred:
- Protein degradation mechanisms; regulated/GLP assay qualification/validation/transfer (ICH Q2, USP).
- Represent analytical function on project teams; complex glycan analysis; analysis across modalities (mAb, ADC, fusion proteins).
Skills (examples): Analytical/assay development; chromatographic techniques; HRMS/LC-MS; Process Analytical Technology (PAT); protein analysis; cross-functional teamwork.
Benefits (if applicable): Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application: Apply via https://jobs.merck.com/us/en (current employees via Workday Jobs Hub). Application deadline listed on the posting; job posting end date effective until 11:59:59 PM the day before 06/12/2026. Requisition ID: R399133.