Manufacturing Supervisor

Salary: $80k - $120k

Shifts: 1st & 2nd

Wed to Saturday schedule or Sunday to Wednesday shifts

4x10 and 3x12 (schedule rotates from week to week).

Schedule alternates from one week 4 days -10 hrs. next week 3 days-12 hours day

Overview

The Supervisor for Aseptic Manufacturing oversees the production process to ensure that all materials are produced safely and follow the company's standards. This position requires timely document review and ensuring all targets are met. In addition, the supervisor will be responsible for developing staff and implementing an effective "First-time right" program to meet Iovance's growing demands. The successful candidate will also help onboard new team members and manage deviations and CAPAs for the training and learning team. It is crucial that the supervisor has innovative technical knowledge and contributes significantly to the overall manufacturing operation. As a leadership team member for autologous cell therapy manufacturing operations, a background in cell culture and manufacturing in ISO class 5 cleanrooms is necessary.

Essential Functions and Responsibilities

• Supervision and Development direct reports (operators), mentoring/coaching to motivate and mentor peers/ staff to foster a culture of continuous improvement and operational excellence.
• Schedule and coordinate day-to-day activities, ensuring conformance to the daily schedule.
• Develop a comprehensive understanding of the current production process, as this role is viewed as a subject matter expert within a specific area. Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility are required.
• Provide oversight of the manufacturing process, ensuring technicians follow cGMP practices and utilize proper aseptic techniques.
• Review batch documentation and logbooks for completeness and accuracy.
• Ability to work under limited supervision and handle problems of a more complex nature.
• Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of the operation.
• Establish objectives and conduct performance reviews, monitor progress toward goals, and provide timely feedback to Management.
• Author and revise documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
• Ensure the department understands and complies with quality standards and requirements as documented.
• Ensure efficient operations and compliance with cGMPs and safety regulations.
• Work in a cleanroom with biohazards, human blood components, and chemicals
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.