Nicholas M. Cocco

** ****** **** **, *********, MA 01420

978-***-****

ac0b4o@r.postjobfree.com

PROFESSIONAL SUMMARY

Biotech professional with proven team leadership skills to work cohesively in a team environment within production with strong communication skills, and motivated to meet all company goals.

AREAS OF EXPERTISE

CIPs/SOPs/cGMPs

Training

Filtration/ Automated systems

Attention to detail

Documentation

Organized and precise (RTFT)

Computer skills: SAP, Foxboro, Windows, Maximo, Lynx, Excel, Word, Citrix, Lab Ware, Mini Tab.

WORK HISTORY

Senior Manufacturing Technician, Abbvie Bioresearch, Worcester Ma. 2002-2016

In this role, provided support to 4 areas of operations with expertise and discipline.

Core Support/Glass wash

Performed daily scheduling, assembling, executing and collecting data of autoclaved equipment for all areas of production.

Trained and mentored new employees on procedures including sampling techniques, record- keeping, autoclaving, CIPs and SIPs, inspections, and troubleshooting of equipment.

Executed CIPs of 50 to 600 liter tanks, filter housing and bases while adhering to Sop’s and cGmp documentation practices.

Maintained equipment log books in glass wash areas.

Examined and scheduled monthly maintenance of glass washers for readiness.

Initiated and completed inspections of small 200L-1000L tanks for cleanliness.

Evaluated and ordered equipment for (Kanban) area, in collaboration with inventory control group.

Prepared and collected samples of washers and CIP equipment using aseptic techniques.

Troubleshooting autoclaves, depyrogenation ovens and glasswashers.

Executed qualification of autoclaves in collaboration with engineering group.

Awarded two silver awards for contributions in qualifying new autoclaves.

Authored revisions of documentation SOPs.

Selected as Safety Coordinator (2013).

Nicholas M. Cocco

Core Support/Buffer Prep

Scheduled and executed daily activities including production processing as well as set-up of equipment, i.e.; SIPs, water sampling of WFI drops, pH meters, scale calibrations, and buffer preparations using Foxboro DCS and SAP computer systems.

Prioritized and distributed daily tasks in collaboration with team members in order to achieve area goals.

Performed and verify batch records for review using SAP.

Provided technical training to area personnel.

Authored revisions of batch record documentation SOPs.

Adhered to all safety procedures, including wearing personal protective equipment.

Participated in aseptic sampling and sterile filtrations of buffer solutions using rhino pump systems, as well integrity pressure testing, using flow star integrity testers.

Scheduled and initiated work orders.

Collaborated with maintenance on changeover protocols.

Performed equipment build for use in daily activities, (i.e.) Carboys, filter housings, buffer disposable equipment and spinner bottles.

Performed cell culture CIPs, SIPs of reactors following documentation procedures.

Transferred buffer solutions using sterilized transfer lines and filter housings to bioreactors in cell culture group.

Performed integrity testing of buffer filters after solution transfers.

Maintained log books.

Core Support/Media Prep

Scheduled and executed media preparations including set up of equipment, i.e.; SIPs, water sampling of WFI drops, pH meters, scale calibrations and solution preparations using Foxboro DCS and SAP computer systems.

Performed Cuno filtration set ups and qualifications with team members.

Scheduled, formulated and executed small scale media preparations with team associates.

Collaborated with inventory control group for ordering of materials and equipment.

Inspected all scales, meters, pipette samplers and osmolality machines.

Trained and mentored junior personnel on cleaning procedures of area fume hoods, aseptic sampling procedures and maintenance of class 10,000 laminar/fume hoods following cGmps documentation.

Formulated and produced small scale media for QC and production use, using various types of media filters and equipment including Cuno and Millipore 10” inch to 30”capsule filter housings.

Performed heating and cooling operations of media solutions using heat exchangers.

Responsible for all data entry and log books.

Writing and reviewing of SOPs.

Perform and verify batch records in SAP.

Nicholas M. Cocco

Senior Manufacturing Technician, Abbott Bioresearch, Worcester, MA 1997-2002

At this time I worked in the Purification group producing over 30 million dollars of Adalimumab (Humira), Juvenile Arthritis (JA) Ankylosing spondylitis final bulk drug product per year.

Purification

Executed purification production process operations with focus on CIPs, SIPs, and COPs of purification tanks, filter skids and UF/DF systems as well as transfer lines.

Accurately followed oral and automated procedures per sop documentation.

Formulated and calculated various resins for use to pack column beds.

Performed packing and unpacking various sized columns per SOPs.

Performed column qualifications, equilibrations, sanitizations and storage per documentation SOPs.

Authored and revised purification SOP’s.

Collaborated with process development group on streamlining production processes.

Maintained class 10,000 to 1,000 HPLC laminar flow area.

Calibrated and operated spectrophotometers.

Calculated mathematical HETP qualifications per SOPs.

Completed inventory tracking of consumables.

Performed UF/DF processing for final concentration of bulk drug substance.

Inspected final bulk fill bottling containers for clarity.

Performed viral deactivation using Millipore 0.45uM filtration capsule filters.

Performed UF/DF qualification and maintenance that includes assembly and disassembly of 30k filtration cartridges.

Submitted data entry information into log books.

Senior Manufacturing Technician I Genetics Institute, Andover, MA 1989-1997

Demonstrated leadership qualities by distributing out daily assignments to 10 technicians, coordinating between 3 departments, 4 suites, and 2 shifts, as well as training new employees.

Signed off on all training and performance evaluations.

Executed aseptic techniques, following SOPs per cGMP protocols.

Prepared media and buffer solutions for factor VII, FIX, BMP and IL-11.

Performed CIP/COP/SIP systems of tanks, filter carts, and transfer lines.

Utilized filtration equipment, autoclaves, depyrogenation ovens, and glass wash systems.

Worked with supervisors on monthly schedules and programs.

Prepared chemical inventory for MCAS system.

Trouble shooting of autoclaves and depyrogenation ovens.

Document formulation records, charts recorders. Log Books.

Daily calibration of process equipment which include pH meters, conductivity meters, osmolality, and scales.

EDUCATION

Fitchburg State University, Fitchburg, MA

Systems and Circuits

OSHA Certification

Writing

Mount Wachusett Community College, Gardner, MA

Quality Technician Training Certificate.

Quality Systems Training Certificate.

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