R&D Partners
Job Description
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.
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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.
Related Jobs
Quality Complaint Contractor — San Diego Metro Area, CA
Production Technician — Bethesda Metro Area, MD
Scientist — Tucson Metro Area, AZ
#J-18808-Ljbffr