QC Associate Scientist
About The Position
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.
Requirements
- Analytical support for GMP manufacturing and process development.
- 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.
- Work cross-functionally with internal departments and external resources on QC related issues.
- Support adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs).
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
