Fill:- Set up and operate vial washer and depyrogenation oven for sterilization.- Prepare and assemble filler components for autoclaving.- Transfer product from tanks to the filler area using aseptic connections.- Operate tray loaders for vials and prepare for inspection.- Ongoing training on filler set up and other aseptic processes.- Review batch records and input data for acceptable vials and rejects.Bulk:- Set up equipment for CIP/SIP prior to bulk process.- Formulate Dextrose/Lysine and Saline solution for emulsification and diafiltration.- Weigh and formulate Lipid combo with aqueous solution for bulking process.- Take rinse water samples and product samples for testing.- Operate HMI (Human Machine Interface) controls for running bulk process.- Create process improvements for safety and ease of operation.- Revise SOPs and batch records.

- Lead the DG Growth group in the manufacture of Dermagraft patches for diabetic foot ulcers from seeding of cells to harvest.- Performed aseptic connections of tubing and CPC connections for processes.- Performed cell seeding and growth through incubation, media drain and fill, Cryo formulation, preservation and harvest operations.- Trained new operators in all aspects of cell growth.- Applied continuous process improvement in growth processes.- Performed scheduling and final document review.

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- Performed simple column chromatography and other diafiltration processes, weighed materials and formulated solutions for Phase II clinical operations.- Sterilized and set up filler equipment and performed aseptic operations in clean rooms.- Sanitized clean rooms, tanks and ancillary equipment.- Wrote procedures and reports, revised MBRs, SOPs and created illustrated assembly drawings.- Maintained and reviewed logbook entries in clean rooms.- Maintained and did troubleshooting of production equipment such as pumps, motors and valves.- Created new setups for engineering protocols for advancement of product trials.- Assisted with calibration, validation, and communicated issues with internal departments.

- Designed dry room, pump room and machine layout for the FlexSure product manufacturing- Performed striping and lamination processes producing test strips for diagnostic tests - Trained personnel in the operation of vacuum pumps, drying chambers, automated pick and place assembly machines, auto pouchers & video measuring systems - Member of the Validation Team performing IQ’s, OQ’s and PQ’s on new machineries- Designed and built an automated card feeder magazine eliminating manual labor- Manufacturing Department representative, Environmental Health and Safety Committee- Department Calibration Representative

- Operated filler machines, labelers, printers, lyophilizers, and lamination presses- Packaging Quality In-Process and Final Kit Inspector- Designed packaging boxes for Packaging Engineering- Department mechanic, craftsman and operator trainer