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.
Required Education, Skills, and Knowledge
- Minimum B.S. in biology, biochemistry, bioengineering, related technical field, or equivalent industry and technical experience.
- Minimum of 5 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
A minimum of 2 years in a Lead / Leadership / Supervisory Role is desired.
- Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
- Strong knowledge and experience of the end-to-end learning process, i.e., learning needs assessment, program design and delivery, and learning evaluation and training effectiveness assessment.
- Demonstrates strong oral and written communication skills and actively contributes to training, report generation, and documentation (batch records, deviations, etc.
Strong technical writing ability is required.
- Experience leading development initiatives, i.e., training, coaching, and learning initiatives.
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