Job Position:
We are seeking a detail-oriented and analytical Bioanalytical Professional to join our team in the quality control department.
* The selected candidate will be responsible for performing various bioanalytical processes to support bulk drug substance manufacture in a regulated environment.
* Responsibilities include ensuring work is compliant with current GMP and regulatory standards, company policies, and standard operating procedures (SOPs).
* The professional will review data from other analysts for accuracy and completeness.
* They will also perform gel/separations assays (CE-SDS/SDS-PAGE, iCIEF, PICO MCE, Western Blot) in compliance with cGMP practices.
* Data processing using Empower software will be performed by the selected candidate.
* Maintaining laboratory reagents and supplies, preparing reagent aliquots and buffers for use in assays, and maintaining equipment in the laboratory are also essential responsibilities.
* The professional will conduct laboratory investigations and generate reports in response to invalid assays, deviations, OOS/OOT.
* Additionally, they will initiate and complete CAPAs in accordance with site procedures.
* New and updated SOPs will be written as needed by the selected candidate.
* Presenting bioanalytical data reports clearly and concisely to management will also be a responsibility of the job.
* The professional will identify and implement lab process improvements and lean initiatives.
Requirements:
* A degree in Life Sciences or a related field is required, or an equivalent combination of education and experience.
* The ideal candidate should have 2+ years' experience working in a regulated testing environment.
* Previous experience working in a regulated Biotech environment is advantageous but not necessary.