CARLOS AUGUSTO CONINCK

** ******* **, ******, ** 02148 781-***-**** acdwql@r.postjobfree.com

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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