Biopharmaceutical Operations Manager

1 day ago


Philadelphia, Pennsylvania, United States R&D Partners Full time
Job Overview

We are seeking a Biopharmaceutical Operations Manager to join our team at R&D Partners.

About the Role

This 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.
Requirements
  • 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.
Compensation Package

We offer a competitive salary range of $120,000 - $180,000 per annum, depending on experience and qualifications.



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