Protein Purification Manufacturing Associate

Paul E.McDougald

** ******* ** *** *

Taunton MA 02780

E mail: ****************@*****.***

Phone# 774-***-****

WORK HISTORY

March 2020 – Present Organogenesis Inc. Norwood MA, Human Tissue Manufacturing /

Team Lead

Training program using Smart Solve.

Trained in GMPs and cGMPs.

Safety and Health.

Biohazards.

Attend Safety Committee Meetings.

Puraply Production for Fortaflex department / Canton MA.

Production Support department / Canton MA.

ReNu Process Runs: Development, Engineering, Validation, Stability, Clinical, APV /

Norwood MA.

ReNu Refresher runs / Norwood MA.

Deviation report procedure.

Change Control procedure.

Ensure SOPs and Forms have the latest version for Process rooms / HTM Norwood.

Ensure gowning and lab supplies are well stocked and not expired.

Preparing equipment for the Affinity and Novachor Process / Norwood MA.

May 2013 – April 2018 (Laid off) Sanofi Corporation. Allston, MA. Downstream Manufacturing Associate

Preparing buffers for a large scale manufacturing facility

Performing CIPs and SIPs

Assign to the disposable buffer bag project using Delta V preparing solution buffers for the protein purification process.

Apex data system.

Aetna transaction system

Jan 2003 – Nov 2012 Biogenidec Inc. Cambridge, MA / Jan 2004 Downstream Manufacturing Associate IV (Night shift) Performing all process operations in a small scale manufacturing facility.

Assign to Downstream Purification Department to continue performing Protein Purification process.

Jul 2001 – Dec 2002 Biogenidec Inc. Cambridge, MA / Jul 2001 Downstream Manufacturing Associate III.

Performed procedures on Bioreactors for the Cell Culture department according to SOPs.

Performed procedures in Downstream Protein Purification department according to SOPs.

Trained in GMPs and cGMPs

Bioreactor procedures

CIPs and SIPs

Delta V

Ultra Filtration, Viral Filtration, Viral Inactivation

Column Chromatography Systems, Automated Chromatography Systems.

Column packing operations

Final bulk bottling

Trained and performed procedures for four different departments according to SOPs.

Dec 1998 – Jul 2001 Biogenidec Inc. Cambridge, MA Process Operator II.

Trained in the independent function of all SOPs related to the production support.

Sanitization of production equipment and preparation for autoclave sterilization.

Prepared Buffers and media for the Dispensary department according to SOPs.

Revised and created SOPs.

Trained and assisted in Validation Protocols / Autoclave load patterns and stand up freezers.

Ability to trouble shoot process issues.

Feb 1994 – Jul 1998 Serono Laboratories Inc. Randolph, MA Manufacturing Technician I

1994 – 1995

1995 – 1998 Manufacturing Technician II / Team Leader.

Trained in GMPs and cGMPs.

Performed procedures according to SOPs.

Understand the scheduling of interdepartmental laboratory processes and worked with other departments to meet their needs.

Sanitization of production equipment and preparation for autoclave sterilization for protein Purification and Cell Culture departments.

Disposal of liquid waste in a GMP facility.

Trained new employees and aided in developing the skills of existing employees.

EDUCATION

Brockton High School Brockton MA Graduate Diploma 1984

CERTIFICATE

1998 Minuteman Science Technology School / Lexington, MA

Instrumentation for Biomanufacturing.

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