Associate Scientist 2 - Analytical Development
About the role
At MilliporeSigma, as an Associate Scientist 2 - Analytical Development, you will work closely with subject matter experts (SMEs) to support analytical method development/validation and feasibility/transfer within the Analytical Laboratory as part of the Analytical & Bioassay department. You are responsible for the scientific integrity of technical work performed in the laboratory, and are required to make scientific observations, maintain detailed workbooks/documentation and ensure all documentation fulfills generally accepted professional/industry standards. Requirements also include maintaining a thorough understanding of company testing services, technical principles, laboratory operations, and applicable technologies to support the successful development and implementation of analytical methods for clinical and commercial products.
Responsibilities
- Understand GMP requirements for analytical method validation, transfer and associated documentation.
- Support analytical method development/validation and feasibility/transfer activities, ensuring studies are initiated and completed on schedule.
- Execute analytical methods in the lab with minimal supervision within constraints of lab scheduling to support development/validation and feasibility/transfer.
- Perform analytical testing in accordance with SOPs and cGMP regulations.
- Maintain complete and comprehensive records for study integrity.
- Make detailed observations and document results.
- Demonstrate consistently high levels of quality work.
- Operate and maintain lab equipment as required by SOPs and testing procedures.
- Utilize applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, etc.).
- Utilize problem solving/troubleshooting skills.
- Communicate deviations/events, progress and interim results to SME.
- Inform SME/supervisor of deviations