Manufacturing Technician
Resume:
CARLOS AUGUSTO CONINCK
** ******* **, ******, ** 02148 781-***-**** **************@*****.***
SUMMARY:
* Fourteen years experience in Biotechnology/Pharmaceutical Companies as Senior Technician
* Assisted and validated three start-up manufacturing facilities: Xcellerex, Abbott, and Centocor- Johnson & Johnson
* Excellent skills in Pilot Plant, Process Development and Cell Culture Manufactory
* Worked in Permanent Perfusion, Feed batch and Stander Batch
* Knowledge in Media Toxicology Cell Study for amino acid, vitamin and supplements
* Experience in cGMP, SOPs and BPRs
* Developed proficiency using Microsoft Office Suite, i.e. Word, Excel, and Outlook
Work experience:
Histogenics, Waltham, MA
Sr Manufacturing Associate 02/2012 – 05/2013
* Performing Standard Cell Culture And Aseptic processing techniques
* Isolating of cells from Cartilage Biopsy
* Supporting and maintaining Cell Culture
* Seeding of cells into 3D Matrix and loading of Matrix Into a custom Bioreactor
* Aseptic packaging of the final product
* Maintaining product segregation between patient specific lots for an Autologous Product
* Preparing of aliquots for used in stages of the Cell Culture process
* Monitoring and stocking manufacturing inventory of raw materials and aliquots
* Reviewing of SOPs and providing suggestions on revisions
* Responsible for routine cleaning of equipment, shelving, benches and carts within the GMP environment
* Performing daily monitoring of facility, equipment and process
* Performing and verifying each Manufacturing Process And Qualification
* Successfully executing an Aseptic Qualification of the process using TBS
* Responsible for assemble, disassembly and cleaning of intricate custom Bioreactor
* Cleaning and sterilizing reusable materials for use in the Manufacturing Process
Anika Therapeutics, Woburn, MA
Manufacturing Associate 10/2010 – 06/2011 Contract
* Followed Batch Records in order to perform dissolution, reaction, filtration, formulation and fill activities for Aseptic and terminally Sterilized Products
* Adhered strictly to written work instructions in order to perform clean out of place,
* Autoclaved of complex equipment and components
* Followed job specific SOPs that support Batch Record and written work instruction execution
* Documented all work activities according to Good Documentation Practices
* Reviewed and revised procedures to ensure work instructions reflect current Manufacturing Practices
* Demonstrated proper aseptic gowning and performed room sanitization activities
* Participated in equipment and processed validation activities
* Reported procedural deviations and non conformances to management
* Participated in root cause analysis and implemented corrective action under the guidance of management
Histogenics, Waltham, MA
Sr Manufacturing Associate 01/2010 – 09/2010 Contract
* Performed Standard Cell Culture And Aseptic processing techniques
* Isolated of cells from Cartilage Biopsy
* Supported and maintained Cell Culture
* Seeded of cells into 3D Matrix and loading of Matrix into a custom Bioreactor
* Aseptic packaging of the final product
* Maintained product segregation between patient specific lots for an Autologous Product
* Prepared of aliquots for used in stages of the Cell Culture process
* Monitored and stocked manufacturing inventory of raw materials and aliquots
* Reviewed of SOPS and provided suggestions on revisions
* Responsible for routine cleaning of equipment, shelving, benches and carts within the GMP environment
* Performed daily monitoring of facility, equipment and process
* Performed and verified each Manufacturing Process And Qualification
* Successfully executed an Aseptic Qualification of the process using TBS
* Responsible for assemble, disassembly and cleaning of intricate custom bioreactor
Biotest Pharmaceutical, Boca Raton, FL
Manufacturing Technician I 05/2009 – 09/2009 Contract
* Manipulated Column Chromatography to isolate desired compounds essential to process
* Manipulated filtration methods to supports Plasma Protein manufacturing processing
* Assembled processing equipment(e.g. tanks, filter housings, mixers, etc)
* Operated Semi-Automated Continuous Flow Centrifuges
* Performed Autoclave Operation and troubleshooting
* Cleaned all equipment and utensils used in the Manufacturing Process
* Performed pH, conductivity measurements, TOC sampling, and filter integrity testing
* Maintained raw material, equipment and area logs, and tracked supply inventories
* Prepared Buffers used in the Purification Process
Massachusetts Biologic Laboratories, Mattapan, MA
Manufacturing Associate III 02/2008 – 08/2008
* Cell Line of Hepatitis C (HCV)
* Performed SEED on 150L Reactor
* Performed transfer from 150L to 1000L and 2500L Reactor
* Executed daily routines as pH meter and Nova Bioprofile 400
* Monitored bioreactors
* Prepared Buffers, Media and Stock Solutions
Xcellerex, Marlborough, MA
Senior Pilot Plant Associate 03/2006 – 09/2007
* Performed Cell Line skills: Hybridoma, Mammalian (CHO cells), Insect, Viro, and Bacterial/Yeast
* Oversaw the daily operations in Production areas
* Oversaw production of Clinical And Commercial Products including the accurate and timely completion of production related cGMP documentation
* Supervised of contractors and consulted for non-manufacturing Xcellerex personnel
* Executed GMP manufacturing operations as required
* Supported Process Development and Pilot Plant
* Performed assembling, compounding, filtering disposable bioreactors bags
* Skilled in aseptic techniques under cGMP productions
Bio-Concept Laboratories, Inc.; Derry, NH
Manufacturing Associate 05/2004 – 08/2005
* Assisted in QA on Batch Records preparation
* Performed assembling, compounding, filtering, filling, inspecting and labeling of products
* Supported Process Engineering and Product Development
* Revised SOPs and Batch Records
* Performed SOPs in autoclave, depyrogeneration, and validation
Biogen, Cambridge, MA
Process Technician III, Cell Culture Manufacturing 11/2002 – 08/2003
* Maintained cell viability/density, and monitored the Cell Line
* Oversaw Micro Filtration (MF)
* Performed and verified calculations and measurements to insure that Batches maintain high quality standards
* Oversaw sterile sampling Bioreactors to monitor cell perform criteria
* Maintained area under cGMP and followed appropriate SOPs/BPRs
* Performed CIP/SIP operations as required
Abbott, Worcester, MA
Process Technician IV, Cell Culture Manufacturing 02/2001 – 08/2001
* Oversaw sterile sampling 6000L Bioreactors to monitor cell perform criteria
* Maintained cell viability/density, and pH
* Assisted validation groups with equipment validation activities
* Verified all equipment instruments are maintained and calibrated
* Performed CIP/SIP operations as required
Centocor- Johnson & Johnson, Malvern, PA
Process Technician IV, Cell Culture Manufacturing 08/1999 – 02/2001
* Maintained cell viability/density, and culture of the cells
* Maintained area under cGMP and followed appropriate SOPs/BPRs
* Assisted validation groups with equipment validation activities
* Assisted the protein A operators in the transfer of cell harvest material form thru hold tanks into protein A area
* Verified all equipment instruments are maintained and calibrated
* Performed CIP/SIP operations as required
Education:
Biotech for Beginners, Centocor University, Marlven, PA (Certificate)
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