STAT Team Lead, 2nd shift
Responsibilities include but are not limited to:
- Lead a small night shift team of Analysts. This individual will have continual interaction with members of his/her team as well as other teams throughout the facility in order to exchange information regarding testing completed, in process and planned. The Team Lead will have daily contact with her/his supervisory staff for work assignments, coaching and general management discussions.
- Work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials. As essential personnel, when on shift, the applicant will be required to work holidays, during inclement weather, and occasional overtime to meet project timelines when required.
- Observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending and implementing corrective actions.
- Perform routine assays such as UV-VIS Spectrometry, TOC, and more complex assays including various HPLC methodologies, as well as lead equipment troubleshooting activities and investigate out of specification results. Individual may support method transfer testing.
- Perform data review of in-process and Bulk Drug Substance samples in a cGMP compliant environment.
- Train less experienced analysts on basic and complex test methods.
- Write and revise SOPs for managerial review and approval as well as write technical reports (for example Investigations or Qualification) and perform data analysis and trending for both method transfers and investigations.