TAVARRES WRIGHT

Oversee daily operations of the Upstream Passage Department. Conduct meetings, scheduling of staff and work assignments. Initiate deviations in Trackwise, perform Real Time Review of completed batch records and logbooks. Initiate Item Request Forms for materials from the warehouse.

Train and sign off associates. Counseled and builds positive teamwork environment. Troubleshoot equipment. Works closely with management and supervision to keep abreast of current and new manufacturing processes, projects, GMP and SOP’s. Ability to work under time constraints with shifting priorities.

Supervised upstream cGMP related activities which included small and large scale of cell culture, transfection, bioreactor/fermenter-based production processes. Troubleshooted processes and equipment. Lead downstream related activities including ultrafiltration/diafiltration, clarification, harvest, and final fill.
Draft, revise, and review various manufacturing documents such as SOP’s, work protocols, deviations, master batch records, and raw materials specifications. Provided classroom and hands on aseptic technique and technical training and coaching. 5S and monitored, cleaned, prepared and operated automated cell processing. Worked with Cell Expansion, filling equipment in Grade B and C rooms. Manufactured clinical and commercial viral therapeutics in cGMP cleanrooms.

Managed daily manufacturing operations of the production/manufacturing floor to ensure daily goals are accomplished, identify, troubleshoot, and resolve operations issues.

Conducted supervisor meetings and Tier Meetings. Sent out shift summary reports, write and issue reprimands when needed. Generated operational protocols, internal or external documents including SOPs, BPRs, and deviations. Worked with Process Development Team and collaborated with Manufacturing Sciences and Technology (MS&T) to transfer new projects into GMPs. Worked with Facilities and Validation to maintain manufacturing equipment.

Participated in facility expansion and equipment validation activities. Trained and sign off associates to perform processes, assigning work duties, scheduling, demonstrated and followed GMP, support production lines in the Clean Room. Performed Real Time Review of batch records.

Assist in creating cell banks using aseptic techniques, operated in the Biological Safety Cabinet (BSC). Conducted BSC trainings for qualification and requalification’s.

Performed proper line clearances to ensure previous batches, labels, and other pertinent documentation were cleared before the start of a new batch. Check work area for cleanliness and prep for upcoming batches. Monitor gauges to ensure parameters for temperature and humidity are in specification.

Point of contact for management and quality assurance for report updates on operations progress. Ensure all environmental health and safety guidelines are followed. Review and revise manufacturing batch records and logbooks. Collect samples for quality assurance. Inspect all finished products before submitting lots to quality assurance.

Assisted with the commencing of EBM (Electronic Batch Management) and Delta V program. Troubleshooted processing equipment. Assisted with harvesting, extracting final product (in paste form) from centrifuge. Aseptic sampling of final goods during harvest for quality testing.

Visual inspection inspected final products to identify any discrepancies (denaturing, metal shavings or debris from equipment) and any findings and report the problems to Management and Quality Assurance. Conduct CIP and COP of equipment and assist with equipment set-ups.

Aseptically removed waste and preserved cells through dilution, centrifugation and siphoning in an ISO 5 and ISO 7 environment. BSC processing and cleaning. Preformed EM monitoring in the BSC using air particle counter machines (MET) and settle plates during BSC processes.

Worked with reagents by adding during processing, prepare final product for shipping, and assist Quality Control with sampling using LIMS (Laboratory Information Management System), ERPLX, assisted with shipping and receiving, and inventory of raw materials.

Visually inspected final products to identify any errors(labels, real time print stamp, color of labels and product). Report finding to supervision, equipment set-up, processing and cleaning of production areas.

Followed all GMP and SOP. Conduct line clearances, completed cleaning log sheets, followed all PPE rules and regulations and count inventory.

Aseptically removed waste and preserved cells through dilution, centrifugation and siphoning in an ISO 5 and ISO 7 environment. BSC processing and cleaning. Preformed EM monitoring in the BSC

Worked with reagents by adding during processing, prepare final product for shipping, and assist Quality Control with sampling, assisted with shipping and receiving, and inventory of raw materials.