Cynthia Ghizzi
Shrewsbury,MA
Summary
Hardworking Manufacturing Associate offering 15+ years supporting manufacturing needs. Successful working long hours in challenging environments, moving supplies, organizing products and packaging shipments. Excellent history of working well with other team members and pitching in to help achieve team goals. GMP experience working with parenteral medicines to cell and gene therapies. Phase 1 of clinical trials for cancer patients. Performing cell counts. Experience with operating filling and capping equipment to performing visual inspections of final products. Qualified in the gowning process to work in clean rooms and biosafety cabinets. Trained in media and buffer preparation, aliquoting to various single use containers, calibrating and operation of instruments used in the labs. Organized and maintained supplies implemented by the Kanban system. 5S methodology. Work skills include adhering to FDA regulations, Medical Devices, Validation, GMP, and Quality Assurance, SAP, Compliance Quest, Zen, Trackwise and DeltaV.
Overview
29
29
years of professional experience
Work History
MSAT GMP Manufacturing Associate II
MustangBio
11.2021 - 03.2024
- Performed cGMP manufacturing processes in ISO 7 and 5 clean room environments in compliance with QA control documents
- (Batch records, Protocols and SOP's) Created and reviewed SOP's and batch records, opening deviations and change controls using QMS systems as Compliance Quest and Zen QMS
- Independently perform upstream and downstream processing autologous CAR T cell therapy using Nucleo counter, Prodigy, Lovo and Rotea instruments.
- Performed Media and Buffer preparation, Cell Isolation and Formulation and Harvest processes per protocols.
- Performed cell counts and feeding cells as needed.
- Worked in partnership Process Development for tech transfer to manufacturing team Analytical and Quality Control groups.
- Performed in process environmental monitoring using Climet and Lasair air particle units, settle and rodac plates.
- Collaborated with Supply Chain with organizing and maintaining small kitting area for clean room single use consumables and supplies using Kanban system and 5S.
- Experience with CMO for iPSCs.
- Enhanced product quality by conducting thorough inspections and adhering to strict quality control protocols.
Senior Bioreactor Support Associate
JLL @ Bristol Meyers Squibb
01.2019 - 11.2021
- Preparation and set up of bioreactors, including installation of tubing and filters
- Breakdown and disassembly of bioreactors post run
- Operate and maintain autoclaves and parts washers
- Performed analytical testing, equipment maintenance and Biosafety Cabinet (BSC) cleaning
- Assisted scientist with setting up bioreactor stations by calibrating pH and DO probes using Delta V
- Cleaned and stocked lab spaces with consumables.
- Assisted in media buffer preparation.
Manufacturing Associate
Sanofi/Genzyme Corporation
07.2010 - 01.2019
- Operated general manufacturing equipment in accordance with SOP's (ex Autoclave, pH, Osmo and Conductivity meters, filter integrity tester, scales and balances, peristaltic pumps and bio-safety cabinets)
- Cleaned and rinse equipment to be assembled then autoclaved or irradiated for the aseptic filling process
- Attended annual aseptic gowning and technique training.
- Weighed and dispense chemical components required to complete media and buffer preparation per batch record
- Became a subject matter expert for the Sartorius Sartocheck 4 and Sartocheck 4 Plus filter integrity testers
- Programming filter tests for all filter types per manufacturer recommendations Ex. Bubble Point and/or Diffusion
- Created an SOP for operating the testers as well
- Coordinated with other departments in planning the customer buffer and media needs
- Created, review and update process documents (SOP's CAPA's and deviations) using QMS systems.
- Contacted outside vendors for supplies and services when needed
- Attended MERT/ First Aid Responder meetings and completed yearly recertification training to maintain status
- Metrology Liaison duties include scheduling and delivering equipment to be calibrated to the Metrology department
- Independently wrote a technical report for a cleaning verification for a manual cleaning procedure on portable mix tanks.
- Implemented the Kanban system for ordering lab supplies.
- Collaborated effectively with cross-functional teams to troubleshoot issues, optimize processes, and achieve common goals.
Component and Solution Preparation Technician
AstraZeneca Pharmaceutical
08.1995 - 07.2010
- Performed duties in accordance with SOP's, cGMPs and established safety procedures.
- Responsible for cleaning, assembling and sterilization of equipment and components utilized in the filling of aseptically filled products.
- Performed clean in place and steam in place process for transfer lines, tanks, and product contact areas.
- Weighed active pharmaceutical ingredients and excipient.
- Perform filter integrity testing both manually and using Millipore Integrity testers.
- Performed PM's on equipment as needed.
- Trained in programming and operation of Gentige Autoclaves and Huber Component Sterilizers, Lyophylizers and Lytzen ovens.
- Aseptic area training with gowning and aseptic techniques.
- Annual gowning and aseptic techniques refresher course required.
- Component and Solution Preparation subject matter expert.
- Maintained Train the Trainer certification.
- Enhanced equipment performance by conducting regular maintenance and troubleshooting tasks.
- Lead classroom training for Plateau database for SOP's.
Education
Associate of Arts -
Axia College of University of Phoenix
Online2008
Microsoft 2010 Training Bundle -
ITU Online
Online2016
Skills
- Quality Management Systems
- Adaptable learner
- Computer Skills
- Teamwork and Coordination
- Attention to Detail
- Time Management
- Inventory and Stocking
- Continuous Improvement
- Supply organization
Timeline
MSAT GMP Manufacturing Associate II
MustangBio
11.2021 - 03.2024
Senior Bioreactor Support Associate
JLL @ Bristol Meyers Squibb
01.2019 - 11.2021
Manufacturing Associate
Sanofi/Genzyme Corporation
07.2010 - 01.2019
Component and Solution Preparation Technician
AstraZeneca Pharmaceutical
08.1995 - 07.2010
Associate of Arts -
Axia College of University of Phoenix
Microsoft 2010 Training Bundle -
ITU Online
Similar Profiles
Helvert MartinezHelvert Martinez
Quality Control Analyst II at MustangbioQuality Control Analyst II at Mustangbio
Mame NtiMame Nti
Account Receivable Specialist at UMass Memorial HealthAccount Receivable Specialist at UMass Memorial Health
Conor LyonsConor Lyons
Landscape Team Leader at Chris Mark And Sons, Inc. Landscaping And Lawn CareLandscape Team Leader at Chris Mark And Sons, Inc. Landscaping And Lawn Care
Amy AlicandroAmy Alicandro
School Nurse at Worcester AcademySchool Nurse at Worcester Academy
Enmanuel LeonEnmanuel Leon
Network Engineer (Contract) at Liberty ChurchesNetwork Engineer (Contract) at Liberty Churches