QC Associate Scientist/ Scientist (I/II)

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.