R&D Partners is hiring: Aseptic Manufacturing Lead in Philadelphia

Essential Functions and Responsibilities

• Develop a Subject Matter Expert (SME)-level understanding of and can execute as skillfully as well as troubleshoot GMP 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.

Preferred Education, Skills, and Knowledge

• 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 regulatrion
• Proactive, results-oriented, self-starter with experience in a complex manufacturing environment