What are the responsibilities and job description for the Lead Aseptic Manufacturing Technician position at R&D Partners?
The Lead Aseptic Manufacturing Tech role helps provide guidance and leadership to the Aseptic Manufacturing Technicians’ teams. You 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.
Duties:
- Assists with identifying training needs and deliver training sessions and ensure training documentation is maintained.
- Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
- Support documentation needs, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed
Required Education, Skills, and Knowledge
- Bachelor's degree or some post-secondary education.
- 3 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing
