Associate Principal Scientist – Bioassay, Cell Based Sciences, AR&D
Merck
June 25, 2026
On-site
Rahway, NJ
Clinical Research and Development
Key Responsibilities:
- Define potency strategy; develop and optimize immune binding and cell-based assays for biologics development.
- Conduct non-GMP qualification/robustness studies and perform non-GMP sample testing.
- Support potency method transfers and validation at GxP testing laboratories.
- Represent potency on cross-functional product development teams.
- Author/review regulatory submissions and technical reports.
- Mentor junior scientists; maintain accurate lab records.
- Communicate with stakeholders across partner organizations, management, and governance.
Qualifications:
- Ph.D. (min 4 yrs) / M.S. (min 8 yrs) / B.S. (min 12 yrs) in cell biology, immunology, biochemistry, molecular biology, or related field.
- Expertise in cell biology and immunology for designing/developing GxP potency assays across large-molecule modalities (new modality experience preferred).
- Hands-on immune binding and cell-based functional assay development (e.g., stable cell line generation, cytotoxicity assays, ELISAs, flow cytometry, reporter gene assays).
- Working knowledge of QbD and DOE; strong statistical skills.
- Proficiency with bioassay/data tools (SoftMax Pro, JMP, PLA software, GraphPad Prism, Microsoft Office).
- Regulatory guidance/quality standards knowledge; experience authoring/reviewing submissions and interacting with health authorities.
Required Skills:
- Assay/analytical method development; immunoassays; cell-based assays; cytotoxicity; LC-MS/HRMS; immunology; antibody-drug conjugates (ADC); molecular biology.
Preferred Skills:
- Cell biology.
Benefits:
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive medical/dental/vision, retirement (401(k)), paid holidays and vacation.
Application:
- Apply via https://jobs.merck.com/us/en (current employees: Workday Jobs Hub). Deadline per posting; Job Posting End Date: 07/25/2026.
- Define potency strategy; develop and optimize immune binding and cell-based assays for biologics development.
- Conduct non-GMP qualification/robustness studies and perform non-GMP sample testing.
- Support potency method transfers and validation at GxP testing laboratories.
- Represent potency on cross-functional product development teams.
- Author/review regulatory submissions and technical reports.
- Mentor junior scientists; maintain accurate lab records.
- Communicate with stakeholders across partner organizations, management, and governance.
Qualifications:
- Ph.D. (min 4 yrs) / M.S. (min 8 yrs) / B.S. (min 12 yrs) in cell biology, immunology, biochemistry, molecular biology, or related field.
- Expertise in cell biology and immunology for designing/developing GxP potency assays across large-molecule modalities (new modality experience preferred).
- Hands-on immune binding and cell-based functional assay development (e.g., stable cell line generation, cytotoxicity assays, ELISAs, flow cytometry, reporter gene assays).
- Working knowledge of QbD and DOE; strong statistical skills.
- Proficiency with bioassay/data tools (SoftMax Pro, JMP, PLA software, GraphPad Prism, Microsoft Office).
- Regulatory guidance/quality standards knowledge; experience authoring/reviewing submissions and interacting with health authorities.
Required Skills:
- Assay/analytical method development; immunoassays; cell-based assays; cytotoxicity; LC-MS/HRMS; immunology; antibody-drug conjugates (ADC); molecular biology.
Preferred Skills:
- Cell biology.
Benefits:
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive medical/dental/vision, retirement (401(k)), paid holidays and vacation.
Application:
- Apply via https://jobs.merck.com/us/en (current employees: Workday Jobs Hub). Deadline per posting; Job Posting End Date: 07/25/2026.