Compounding Lead (2nd Shift)

About the role

Assist pharmacists and room supervisors to oversee all required activities for the preparation of materials and manual aseptic filling of compounding sterile products within an ISO 7 environment.

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.
• Ensure compliance to SOPs, batch records and HR policies, assisting in disciplinary action as needed.
• Meet Right First Time (RFT) metrics by reducing error / deviations and completing corrections quickly
• Review and maintain adherence to the manufacturing schedules
• Track employee training to ensure compliance
• Aid in bi-annual reviews of procedures
• Aid in on-the-floor leadership to the production team
• Aid in coaching and training of technicians in the manufacturing suites
• Aid in process improvements and scale up initiative within the department
• Manage personnel to operational standards and assist as needed in completing performance evaluations

Requirements

• 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

Qualifications

• Basic understanding of pharmaceutical manufacturing processes
• Strong organizational and time management skills
• Ability to work independently and as part of a team
• Excellent communication and problem-solving skills

Skills

• Knowledge of cGMP regulations
• Experience with aseptic techniques and sterile processing
• Strong attention to detail
• Ability to work in a fast-paced, high-pressure environment

Benefits

• Competitive salary
• Comprehensive benefits
• Performance package
• Opportunity to work for an expanding, international, professional, and ambitious pharmaceutical company

Pay

TBD

Schedule

TBD