Aseptic Manufacturing Lead

The Lead Aseptic Manufacturing Tech role helps provide guidance and leadership to the Aseptic Manufacturing Technicians teams. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. The Lead Manufacturing Technician will be responsible for and lead others in various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use. To excel in this role, the candidate strongly desires a background in cell culture, aseptic gowning, qualification, and ISO class 5 cleanroom operations.

Preferred Education, Skills, and Knowledge

• Minimum 4 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulation
• Proactive, results-oriented, self-starter with experience in a complex manufacturing environment