QC Associate Scientist/ Scientist (I/II)

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

The primary role of the QC Associate Scientist/ Scientist (I/II) is to provide analytical support for GMP manufacturing and process development. The Associate Scientist/ Scientist will work under supervision of senior QC Scientist to develop, qualify, and execute analytical test methods for raw materials, highly potent APIs, antibody-drug conjugates (ADCs), and other pharmaceutical products in a GMP setting. The incumbent works cross-functionally with internal departments and external resources on QC related issues. The QC Associate Scientist/ Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.Job Responsibilities:• Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.• Routine QC testing of RM, In-process samples, DS, DP and stability samples as per the approved procedures in GMP environment.• Develop and execute analytical methods for small molecules, proteins, and antibody-drug conjugates under the supervision of a Senior QC Scientist.• Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. under supervision as needed.• Document work in laboratory notebooks and logbooks according to organizational GDP policies.• Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting under senior QC scientist supervision.• Perform detailed peer review of analytical data to ensure accuracy.• Perform other tasks and assignments as needed and specified by management.