R&D Partners
Overview
The Lead Aseptic Manufacturing Tech role provides 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. A strong background in cell culture, aseptic gowning, qualification, and ISO class 5 cleanroom operations is preferred. Responsibilities
Provide leadership and direction to Aseptic Manufacturing Technicians in daily operations, ensuring compliance with GMP and safety standards. Supervise and participate in cleaning, sanitization, preparation, and filling/packaging activities for commercial and clinical products. Collaborate with cross-functional teams to support manufacturing processes and timelines. Qualifications
Minimum 4 years of experience in biopharmaceutical GMP manufacturing operations, including experience in cell culture and associated downstream processing. Quality mindset; familiarity with 21 CFR Part 11, GxP best practices, and FDA regulations. Proactive, results-oriented, self-starter with experience in a complex manufacturing environment.
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The Lead Aseptic Manufacturing Tech role provides 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. A strong background in cell culture, aseptic gowning, qualification, and ISO class 5 cleanroom operations is preferred. Responsibilities
Provide leadership and direction to Aseptic Manufacturing Technicians in daily operations, ensuring compliance with GMP and safety standards. Supervise and participate in cleaning, sanitization, preparation, and filling/packaging activities for commercial and clinical products. Collaborate with cross-functional teams to support manufacturing processes and timelines. Qualifications
Minimum 4 years of experience in biopharmaceutical GMP manufacturing operations, including experience in cell culture and associated downstream processing. Quality mindset; familiarity with 21 CFR Part 11, GxP best practices, and FDA regulations. Proactive, results-oriented, self-starter with experience in a complex manufacturing environment.
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