SR Cell Therapy Manufacturing Tech

Essential Functions and Responsibilities

• Develop a Subject Matter Expert (SME)-level understanding of and be able to skillfully execute as well as troubleshoot GMP cell therapy manufacturing process(es).
• Complete training sessions and ensure training documentation is maintained.
• Understand and comply with quality standards and requirements as documented.
• 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.

Preferred Qualifications

• Minimum 3 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors. May be given a visual exam for visual acuity and color perception.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.