Senior Biologics Analytical Scientist – ELISA & Cell-Based

msd; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

401(k) retirement plan

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Senior Scientist (R3) in Biologics AR&D GMP Operations to optimize assays, validate methods, and lead transfer activities for ELISA and cell-based assays.

The role collaborates with Analytical Development and QA to manage deliverables and support commercialization efforts. The candidate will work in a fast-paced, multidisciplinary environment, supporting lifecycle management and regulatory submissions while occasionally working evenings or weekends as

Qualifications

• Ph.D. in biology/biochemistry or MS with 3+ years experience or BS with 7+ years experience.
• Deep technical expertise with immunoassays and/or cell-based potency methods.
• Proficiency with ELISAs and mammalian cell culture.
• Strong organizational skills with proven ability to manage timelines and deliverables.
• Ability to identify and communicate risks; lead by influencing others.

Responsibilities

• Execute GMP activities including release, stability, and in-process testing of Biologics DS/DP using analytical tools.
• Validate and implement biologics methods to support release and stability testing.
• Support reagent qualifications and SoftMax Pro template validation.
• Serve as SME across franchises and analytical platforms.
• Support biologics registrations, product launches, and troubleshooting.
• Develop and manage project timelines and deliverables.
• Support audits, inspections, and CAPAs; advance matrixed team initiatives.
• Author and review technical documentation for regulatory submissions.

Skills

Immunoassays

Cell-based potency

Mammalian cell culture

ELISA

Project management

Communication

Leadership

Independent work

Education

PhD in biology/biochemistry

MS + 3+ years experience

BS + 7+ years experience

Tools

SoftMax Pro

LIMS

Electronic notebook

qPCR

Capillary electrophoresis

Chromatography

Job description

Merck & Co., Inc. in Rahway, NJ seeks a Senior Scientist (R3) in Biologics AR&D GMP Operations to optimize assays, validate methods, and lead transfer activities for ELISA and cell-based assays.

The role collaborates with Analytical Development and QA to manage deliverables and support commercialization efforts. The candidate will work in a fast-paced, multidisciplinary environment, supporting lifecycle management and regulatory submissions while occasionally working evenings or weekends as