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Lead Aseptic Manufacturing Specialist
2 months ago
We are seeking a highly skilled and experienced Aseptic Manufacturing Team Lead to join our team at Iovance Biotherapeutics Inc. The successful candidate will be responsible for providing guidance and leadership to our Aseptic Manufacturing Technicians, ensuring the smooth operation of our manufacturing processes, and maintaining the highest standards of quality and safety.
Key Responsibilities- Leadership and Guidance: Provide technical guidance and leadership to Aseptic Manufacturing Technicians, ensuring they have the necessary skills and knowledge to perform their duties effectively.
- Process Optimization: Collaborate with cross-functional teams to optimize manufacturing processes, improve efficiency, and reduce costs.
- Quality Assurance: Ensure that all manufacturing processes and procedures meet the highest standards of quality and safety, and that all regulatory requirements are met.
- Training and Development: Develop and implement training programs to ensure that all team members have the necessary skills and knowledge to perform their duties effectively.
- Communication: Communicate effectively with all stakeholders, including team members, management, and external partners.
- Education: Bachelor's degree in a relevant field, such as biology, chemistry, or engineering.
- Experience: 3+ years of experience in aseptic manufacturing, with a strong background in cell culture and downstream processing.
- Skills: Strong technical knowledge of aseptic processing, excellent leadership and communication skills, and the ability to work effectively in a team environment.
- Certifications: GMP certification and experience with 21 CFR Part 11 and standard GxP best practices.
The successful candidate will work in a cleanroom environment with biohazards, human blood components, and chemicals. They will be required to wear personal protective equipment (PPE) and follow all safety protocols.