QC Associate Scientist/ Scientist (I/II)

Nj Bio; Princeton (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

Nj Bio in Princeton, NJ is seeking 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, APIs, and antibody-drug conjugates under supervision.

The role includes cross-functional collaboration, strict adherence to SOPs and regulatory requirements, and performing QC testing of RM, in-process samples, DS/DP, and stability in a GMP environment.

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.

Job description

Job Details

Job Location: Headquarters- New Jersey - PRINCETON, NJ 08540

Salary Range: $60,000.00 - $80,000.00 Salary/year

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.