Carmelina Minichiello
Saugus,MA
Summary
Responsive Manufacturing Technician with highly developed skills in upstream and purification processes. Sound knowledge of production operations. Sensible Manufacturing Technician offering over 10 years of experience in cGMP environment.
Overview
18
18
years of professional experience
Work History
Senior Manufacturing Technician
Homology Medicines, Inc/Oxford Biomedica Solutions
Bedford, MA
11.2020 - 08.2023
- Trained and supervised production staff in use of equipment and machinery.
- Performed daily maintenance and servicing of equipment to maintain smooth-running operations.
- Calibrated machines to maintain required productivity levels and adherence to quality standards.
- Set-up and operated WAVE, Single use mixers, bioreactors, AKTA Pilot/Ready, and TFF process equipment.
- Preparation of buffers.
- Use of Bio-welders/ sealers, pH meter, OSMO meter, scales, pumps, Autoclave, and parts washer.
- Performed cell culture expansion.
- Operated Genisys-C Automated Filling System.
- Performed vial inspection.
- Use of Bio-safety Cabinets.
- Performed Purification processes.
Lead Manufacturing Technician
Thermo Fisher Scientific Inc.
Framingham, MA
02.2011 - 11.2020
- Made sure that products were produced on time and are of good quality.
- Inspected finished products for quality and adherence to customer specifications.
- Trained and supervised production staff in use of equipment and machinery.
- Performed visual and functional inspection of components to determine quality and identify defects.
- Boxed, labeled, and transported items to support assembly operations.
- Responsible lead for second shift team in Performance Optimized Polymer department.
- Manufactured polymers using bioreactors.
- Scheduled weekly production orders and assignments for first and second shift.
- Filled, capped, labeled, and packaged buffers and polymers.
Certified Pharmacy Technician
Beth Israel Deaconess Medical Center
Boston,MA
11.2005 - 07.2007
- Stocked, labeled, and inventoried medication to keep accurate records.
- Maintained proper drug storage procedures, registries, and records for controlled drugs.
- Assisted in preparation, distribution and storage of pharmaceuticals.
- Counted, measured and compounded medications following standard procedures.
- Performed various pharmacy operational activities with strong commitment to accuracy, efficiency, and service quality.
Education
Associate of Science - Pharmacy Technician
Bunker Hill Community College
Charlestown, MASkills
- Downstream Processing
- Single Use Mixers
- Aseptic Technique
- Upstream Processing
- SOP
- Set-up and shakedown of process equipment
- Deviations
- CAPA's
- Troubleshoot Malfunctions
- Scheduling
- SAP
- cGMP Regulations
Timeline
Senior Manufacturing Technician
Homology Medicines, Inc/Oxford Biomedica Solutions
11.2020 - 08.2023
Lead Manufacturing Technician
Thermo Fisher Scientific Inc.
02.2011 - 11.2020
Certified Pharmacy Technician
Beth Israel Deaconess Medical Center
11.2005 - 07.2007
Associate of Science - Pharmacy Technician
Bunker Hill Community College