Aseptic Manufacturing Lead

Job Description

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.

• Develop a Subject Matter Expert (SME)-level understanding of and can execute as skillfully as well as troubleshootGMP cell therapy manufacturing process(es).
• Assists with identifying training needs, establishing a feedback loop to ensure continuous improvement.
• Deliver training sessions and ensure training documentation is maintained.
• Understand and comply with quality standards and requirements as documented. Ensure training schedules meet company production and quality targets.
• Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
• Perform document review, including executed Batch Records and Logbooks.
• Support documentation needs, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to reflect current procedures accurately.
• Execute documentation Change Controls of SOPs, Batch records, etc., as needed.

• 3+ 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