Compounding Lead

Key Responsibilities

• Successfully pass and remain qualified for entrance into the ISO 7 cleanrooms
• Successfully pass and remain media fill qualified
• Must be able to stand and maneuver around the tight spaces of a cleanroom for upwards of 7 hrs. per day
• Assist in overseeing all ISO 7 cleanroom activities including but not limited to: cleaning of VLFHs, the preparation of materials required to aseptically reconstitute, pool and dilute drug product, manual aseptic filling of drug product, performing calibration checks, environmental plating of operators, and communicating issues with management.
• Avoid errors and deviations, and complete corrections quickly
• Ensure compliance to SOPs, batch records and HR policies, assist in disciplinary action as needed
• Review and maintain adherence to the manufacturing schedules
• Track employee training to ensure compliance
• Aid in bi-annual reviews of procedures
• Provide on-the-floor leadership to the production team
• Aid in coaching and training of technicians in the manufacturing suites
• Support process improvements and scale up initiative within the department
• Manage personnel to operational standards and assist as needed in completing performance evaluations

Basic Qualifications

• ISO 7 Gowning experience required
• GDP experience required
• A strong understanding of cGMP pharmaceutical manufacturing preferred
• Supervision or lead experience preferred
• ISO 5 experience preferred