Lead Aseptic Manufacturing Specialist

1 week ago


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

The Lead Aseptic Manufacturing Specialist plays a crucial role in guiding and overseeing the Aseptic Manufacturing Technician teams. This position necessitates a comprehensive understanding of the theories, techniques, and principles that underpin manufacturing processes. The Lead Specialist will be accountable for leading various tasks, including cleaning, sanitization, preparation, and the fulfillment of products intended for both commercial and clinical applications.

Key Responsibilities

  • Develop a Subject Matter Expert (SME) level of understanding and execute as well as troubleshoot GMP cell therapy manufacturing processes.
  • Assist in identifying training requirements and establish a feedback mechanism to promote continuous improvement.
  • Conduct training sessions and ensure that training documentation is meticulously maintained.
  • Understand and adhere to quality standards and requirements as documented, ensuring that training schedules align with production and quality objectives.
  • Provide operational support functions, including material stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning tasks, and equipment upkeep.
  • Review documentation, including executed Batch Records and Logbooks.
  • Support documentation needs by drafting and approving SOPs, Batch Records, Deviations, CAPAs, etc., and perform necessary revisions to accurately reflect current procedures.
  • Execute documentation Change Controls for SOPs, Batch Records, etc., as required.

Preferred Qualifications

  • Minimum of 3 years of experience in biopharmaceutical GMP manufacturing operations, with a focus on cell culture and downstream processing.
  • Possess a quality-oriented mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Proactive, results-driven individual with experience in a complex manufacturing environment.
About R&D Partners

R&D Partners is a national staffing firm specializing in Scientific, Clinical Research, and Engineering sectors. Our team boasts over 200 years of combined staffing experience, providing consulting, direct hire, and outsourcing solutions. We are committed to understanding our clients' needs and identifying suitable candidates through our extensive network of professionals.

The foundation of our success lies in our knowledgeable and experienced recruiting team, which is uniquely specialized in life sciences, clinical research, and engineering. By establishing strong relationships with experienced passive candidates, we ensure that we can effectively match our candidates' talents with our clients' opportunities when the time is right.



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