Experience

• 

  Allergan

  Feb 2010 - Oct 2010

  Clean room production technician

  Note: Allergan was formerly (LifeCell) at time of employment. -Aseptically processed human tissue in a cleanroom environment.

• 

  Johnson & johnson

  Oct 2010 - Oct 2012

  Senior laboratory technician

  • Manufactured BSA products (Bovine Serum Albumin), Red Cell diluents, medias, reagents, and buffers according to documented procedures and specifications.• Responsible for training coworkers on manufacturing and formulating over 50 different diluents, medias, reagents, and buffers.• Became an SME for Red Cell Diluent Formulation.• Performed in-process assays utilizing instrumentation including pH meter, conductivity meter, osmometer, spectrophotometer, and flame photometer.• Cross trained in Donor Screening/ Reagent Prep department and became fully trained, and trained others in this department.• Formulated several different diluents, buffers, and reagents, which were used to make donor screening products, Red cell products, Antisera products, and other diagnostic products.• Performed various transactions in SAP and SPIDER.• Calibrated and verified instrumentation daily.• Reviewed batch records, logs, and other controlled documents.• Obtained experience revising batch records, SOP’s and other documents.• Completed QERTS and Trackwise training and had experience writing quality events and NC's. Show less

• 

  Ortho clinical diagnostics

  Oct 2012 - May 2017

  Technician ii

  • Processed RhoGAM Anti-D (A commercially manufactured injectable drug derived from human plasma which prevents hemolytic disease of the newborn.) • Spearheaded a yield improvement project that significantly increased product yield.• Created a spreadsheet to track the yield throughout the process, identified areas for improvement, and made suggestions to target process parameters that would increase the yield.• Became the first technician to become fully trained on all manufacturing duties within the department. • Responsible for proficiently training coworkers on different tasks within our department.• Took on the Lead Technician role for the extended shift in which making critical adjustments, performing titrations, and making chemical additions to the batch occurred.• Processed human plasma by means of Cohn Fractionation, Viresolve filtration, and Viral Inactivation.• Obtained Six Sigma Green Belt Training.• Prepared and formulated many different reagents and buffers which were used throughout the process.• Operated machines and equipment including high speed centrifuges, column chromatography systems, Viresolve filtration equipment, concentrators, filters, scales, bottle cutters, pumps, water baths, chart recorders, glycol cooling systems, filter integrity testing machines, mixers, and dissolvers.• Supported supervisors, engineers, mechanics, health and safety, contractors, and product support regularly.• Became the departmental EH&S representative and attended monthly EH&S meetings, and trained coworkers on different EH&S topics regularly.• Helped to make several process improvements within the department.• Performed in process testing utilizing instrumentation such as pH meters, conductivity meters, hydrometers, spectrophotometers, viscometers, and column chromatography systems.• Consistently adhered to all applicable regulations, policies and procedures for health, safety and environmental compliance. Show less

• 

  Minaris regenerative medicine

  Feb 2018 - now

  • Responsible for creating, implementing, and delivering effective and robust training content including: Training Videos, Instructor Manuals, Training Checklists, Equipment Manuals, Process Manuals, Instructor Led PowerPoint Trainings, Exercises, Job Aids, Learning Assessments, and Learning Assessment Answer Keys. • Creating and implementing process specific training courses.• Designated as the CAPA Owner for training related CAPA’s.• Mentoring and Training Cell & Gene Therapy Associates and Technical Trainers on creating, implementing, and delivering effective and robust training content.• Creating and revising Unit Ops Training content for Onboarding skillsets.• Responsible for scheduling and delivering technical training activities related to manufacturing of cell and gene therapy products. Show less • Responsible for scheduling and delivering technical training activities related to clinical manufacturing of cell therapy products. • Responsible for identifying technical training needs and deploying an effective and comprehensive training program.• Responsible for delivering classroom trainings and/or instructor led hands on trainings for; cGMP, GDP, aseptic technique, gowning, cleanroom behavior, aseptic manipulations, Sepax, CliniMACS, LOVO, Plasmatherm, CliniMACS Prodigy, BSC’s, incubators, centrifuges, tube sealers, tube welders, micropipette, pipette aid, control rate freezers, LN2 freezers, environmental monitoring, scales and balances, refrigerators, freezers, ultra-cold freezers, environmental alarm response, gas delivery system, HVAC, material transport, calculations, verifier training, train the trainer and more. • Helped to implement a train the trainer program for operators and trainers.• Responsible for training new hires on aseptic processing manipulations and prepared them for operator aseptic qualifications.• Created and revised technical training materials regularly.• Responsible for developing and adhering to a training plan based on business needs.• Performing and verifying operator aseptic qualifications.• Supported investigations and worked on CAPAs related to processing and training.• Demonstrated strong aseptic technique and taught trainees the importance of aseptic technique.• Continuously evaluated the technical training program and made improvements to trainings regularly.• Trained and mentored technical trainers and CGTA’s preparing them to effectively deliver various ILT trainings.• Observed associates during production activities and provided them with feedback regularly.• Provided technical writing support for training related processes and procedures. Show less • Responsible for aseptically processing Cell Therapy products for clinical use and in compliance with cGMP’s, SOP’s, BTR’s, and specifications. • Participated in the technical transfer of one of our client’s processes.• Worked with clients, MSAT, QA, and other manufacturing associates to help make process improvements, batch record changes, and SOP changes. • Became fully trained in two different cell therapy manufacturing processes. • Responsible for delivering in-process training.• Responsible for training coworkers on operator aseptic qualifications and process related activities in a positive and effective way. • Obtained experience making different cytokine and media preparations. • Taught trainees the importance of aseptic technique• Performed micropipette qualifications.• Provided trainees and less experienced coworkers with as much knowledge and experience as possible during training's and encouraged them to ask questions.• Obtained further experience on writing NOE’s, PDR’s, and Deviations. • Obtained experience operating, CliniMACS, Sepax, LOVO, CliniMACS Prodigy, controlled- rate freezers, temperature monitoring systems, alarm systems, BSC’s, CO2 incubators, liquid nitrogen freezers, pipettes, refrigerators, ultra- cold freezers, laser particle counters, water baths, tube sealers, tube welders, dry shippers, cryocarts, ductless enclosures, centrifuges, scales, densitometers, peristaltic pumps, pump-scale systems, and more. • Reviewed logbooks, forms, and batch records regularly for accuracy and other documentation errors.• Helped prevent deviations by collaborating with coworkers and clients and offering suggestions when critical decisions had to be made. Show less

  • Senior Technical Trainer

    May 2021 - now

  • Technical Trainer

    Apr 2019 - May 2021

  • Manufacturing Associate II (Cell & Gene Therapy)

    Feb 2018 - Apr 2019