Biopharmaceutical Operations Manager
1 day ago
We are seeking a Biopharmaceutical Operations Manager to join our team at R&D Partners.
About the RoleThis is an exceptional opportunity to work with our clients in the life sciences industry, utilizing your expertise in GMP cell therapy manufacturing operations. As a Biopharmaceutical Operations Manager, you will be responsible for developing and executing process improvements, ensuring quality standards, and providing operational support functions.
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.
- 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.
We offer a competitive salary range of $120,000 - $180,000 per annum, depending on experience and qualifications.
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