GMP QC Scientist I/II — Analytical Methods & ADCs

NJ Bio, Inc.; Princeton (NJ); On-site; USD 65,000 - 95,000; Full time

Job summary

NJ Bio, Inc. in New Jersey seeks a QC Associate Scientist/Scientist I/II to provide analytical support for GMP manufacturing and process development. You will develop, qualify, and execute analytical test methods for raw materials, highly potent APIs, and ADCs under supervision.

You will document work in notebooks, write SOPs, and perform peer reviews of data to ensure cGMP compliance and regulatory readiness. Strong EHS practices and cross-functional collaboration are essential.

Qualifications

• GMP knowledge and compliance with cGMP standards.
• Experience writing or following SOPs and GLP/GDP records.

Responsibilities

• Perform QC testing of RM, in-process, DS/DP, and stability samples in GMP environments.
• Develop and execute analytical methods for small molecules, proteins, and ADCs under supervision.
• Prepare SOPs, test methods, protocols and reports as needed.
• Document work in notebooks and logbooks per GDP policies.
• Write, review, and execute analytical protocols and reports for method transfers and validations.
• Perform detailed peer review of analytical data for accuracy.
• Carry out additional tasks as assigned by management.

Skills

GMP knowledge

Analytical testing

SOP writing

Documentation

Job description

NJ Bio, Inc. in New Jersey seeks a QC Associate Scientist/Scientist I/II to provide analytical support for GMP manufacturing and process development. You will develop, qualify, and execute analytical test methods for raw materials, highly potent APIs, and ADCs under supervision.

You will document work in notebooks, write SOPs, and perform peer reviews of data to ensure cGMP compliance and regulatory readiness. Strong EHS practices and cross-functional collaboration are essential.