Senior Scientist, Bioassay Analytics & GMP R&D

Merck & Co.; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Senior Scientist in Biologics AR&D GMP Operations to optimize assays, validate methods, and manage tech transfers across stages. The role emphasizes ELISA and cell-based potency methods within a multidisciplinary team.

The candidate will collaborate with Analytical Development, QA, and Regulatory Affairs to address challenges, develop documentation, and progress development timelines toward commercialization, with flexible hours as needed.

Qualifications

• PhD in biology/biochemistry or MS with 3+ yrs, or BS with 7+ yrs relevant experience.

Responsibilities

• Execute GMP release, stability, and in-process testing of Biologics DS/DP.
• Validate biologics methods for release and stability testing.
• Support reagent qualifications and SoftMax Pro template validation.
• Act as SME across franchises and analytical platforms.
• Support biologics registrations, launches, and troubleshooting.
• Develop and manage project timelines and deliverables.
• Assist audits, inspections, and CAPA investigations.

Skills

Immunoassays

ELISA

SoftMax Pro

Mammalian cell culture

Analytical leadership

Timeline management

Communication

Education

Ph.D. in biology/biochemistry

M.S. with 3+ years experience

B.S. with 7+ years experience

Tools

LIMS

SoftMax Pro template

Electronic notebook

Job description

Merck & Co., Inc. in Rahway, NJ seeks a Senior Scientist in Biologics AR&D GMP Operations to optimize assays, validate methods, and manage tech transfers across stages. The role emphasizes ELISA and cell-based potency methods within a multidisciplinary team.

The candidate will collaborate with Analytical Development, QA, and Regulatory Affairs to address challenges, develop documentation, and progress development timelines toward commercialization, with flexible hours as needed.