Senior Biologics Analytics Scientist – R&D

Merck; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co., Rahway, NJ, seeks an Associate Principal Scientist for the BAR&D group to tackle complex analytical challenges in biologics drug product development. This laboratory-based role leads method development, qualification, transfer and troubleshooting for monoclonal proteins and other complex biologics, while collaborating across functions and mentoring junior staff.

The candidate will design experiments, interpret data, author reports and contribute to regulatory filings, with emphasis

Qualifications

• Bachelor's degree with 10+ years, MS with 7+ years, or PhD with 3+ years in relevant field.
• Hands-on separation sciences with chromatography or CE for biologics.
• Experience with residual impurity assays using immunoassay techniques.
• Ability to co-design, draft, execute/direct work related to method bridging and reports.
• Excellent communication and cross-functional collaboration.
• Matrix management and peer coaching experience.

Responsibilities

• Develop, qualify, implement, troubleshoot and transfer analytical methods for monoclonal proteins or complex biologics.
• Develop new assay platforms and benchmark against industry standards.
• Provide technical leadership for experimental design and data interpretation.
• Author SOPs, technical reports, and regulatory submissions sections (IND, BLA).
• Collaborate cross-functionally and mentor junior staff.

Skills

Analytical R&D

Biochemistry

Biologics assay development

Chromatography

Cell-based assays

Teamwork

Education

B.S./MS/PhD in related field

Tools

SEC/RP/IEX/HILIC

CE analysis (CE-SDS, iCIEF)

ELISA/qPCR

JMP/MiniTab

Regulatory filings (IND/BLA)

Job description

Merck & Co., Rahway, NJ, seeks an Associate Principal Scientist for the BAR&D group to tackle complex analytical challenges in biologics drug product development. This laboratory-based role leads method development, qualification, transfer and troubleshooting for monoclonal proteins and other complex biologics, while collaborating across functions and mentoring junior staff.

The candidate will design experiments, interpret data, author reports and contribute to regulatory filings, with emphasis