Formulations Supervisor (BS req.)

PRIMARY OBJECTIVES: Manage the daily operation, schedule and function of the formulations department, which provides all chemistry and formulation support for in vivo research. Develop preparation methods if not provided. Document all work for a regulatory environment.

DUTIES AND RESPONSIBILITIES
•Manage the day - to - day formulations/drug compounding operations of the laboratory; arrange for adequate staffing at all times; monitor daily operations to ensure all SOP's are being followed.
•Understand and ensure staff follow all SOP's and Quality Assurance Standards.
•Create, maintain, and review formulations related SOPs to ensure they reflect current work practices.
•Assist with the audits for regulatory and sponsor audits of the facility and studies
•Draft, edit, modify and verify preparation procedures according to protocol / published research/ Project Lead and/or Client instruction.
•Assist w/ the costing of consumable supplies used for studies.
•Assist with ordering drugs, reagents, and lab supplies.
•Recommend drug/dosing regimens in collaboration with the project management team based on published and/or historical data.
•Monitor test materials accountability and re-supply, maintain facilities for regulatory compliance.
•Maintain a clean and safe work environment.
•Maintain test material inventory, lot information, COA, and SDS for test agents and reagents.
•Supervise Formulation Technicians within the lab.
•Ensure the proper training and competency of Formulations staff.
•Provide input into hiring and firing decisions; conduct performance appraisals and provide counseling when needed.
•Involved in quality investigations and resolution and implementation of appropriate corrective action, when necessary.
•Assist with other tasks/duties as need in a small company environment.