Created and implemented new Fill/Finish Department meeting all deadlines to allow filling of drug products to be completed onsite, including aseptic media fill, validation, operator qualifications, visual inspection. Managed technical operations schedule with interdepartmental coordination and communication. Including production scheduling for Upstream manufacturing, Downstream Manufacturing, and Fill/Finish. SME during FDA and QP audits. Responsible for managing upstream, downstream and fill/finish task assignments.
Lead on floor during manufacturing processing (Upstream/Downstream), responsible for issue resolution and troubleshooting on the floor and to properly escalate and communicate any issues that could impact processing. Organized Manufacturing Process Schedule based on doubling time of cell culture and time parameter stated in Batch Records to meets the non-clinical and clinic product needs.
Started-up state of the art clinical/GMP manufacturing facility. Developed and implemented new SOP and Batch Record to meet the needs GMP processing from Process Development protocol. While learning new procedure including bioreactor operations(Sartorius Single-Use 200L/500L) and harvest/filtration operations (single-use). SME for Upstream Manufacturing with FDA and QP audits.
The primary responsibilities of a Cellular Production Associate is to support the production of cellular products for patients participating in clinical protocols in Phase I, II, III and transfer to commerical procedures in a cleanroom environment following applicable regulatory requirements. Protocols include cellular therapy, cell culture, gene therapy and solid tumor/tissue therapy. Managed and executed protocols, including XSCID and TIL.
Worked with other Cell Processing Associates utilizing Good Manufacturing Practices during aseptic processing of clinical and commercial products using Standard Operating Procedures (SOP).One of few manufacturing operation associate to be proficient in final product packaging, apheresis acknowledgment, apheresis receiving, operating, batch record review.
Companies Worked For:
Job Titles Held:
Where can I find a Takeda Pharmaceuticals Manufacturing Trainer, IG Filling and Packaging resume example in Hayward, California ?
This is an actual resume example of a Manufacturing Trainer, IG Filling and Packaging who works in the Biotechnology Industry. LiveCareer has 12147 Biotechnology resumes in its database. LiveCareer’s Resume Directory contains real resumes created by subscribers using LiveCareer’s Resume Builder.
© 2019, Bold Limited. All rights reserved.