GREGORY J. PETROS
3 Dumbarton St.▪ Andover, MA 01810 ▪ 978-475-7377 ▪ email@example.com LinkedIn.com/in/gregpetros
Biotechnology professional with expertise in the start-up and operation of GMP production suites. Extensive experience in commercial and contract manufacturing management combining protein purification and cell culture subject matter expertise with a thorough understanding of cGMP requirements.
Taurus PCC, Genzyme, Allston/Framingham, MA 2013- 2015
Created and managed schedules for the CQV of a Cell Culture Suite, Media Bottling Relocation Project, and the shutdown of two GMP Manufacturing Facilities.
Provided schedule updates, look-a-heads, and critical paths.
Provided guidance/technical assistance to the Project Team with document revisions.
Participated in all project meetings and provided meeting minutes.
Used the shutdown schedules to assist the PM/Project Team with resource management.
Xcellerex, Marlborough, MA 2010-2013
Bioprocess Manager, Manufacturing
Provided leadership for all Manufacturing activities, with particular focus on Safety, Operational Excellence and Manufacturing Productivity.
Led a group of two supervisors and five operators processing in three “single-use” suites.
Utilized teamwork to build effective and productive links within the manufacturing group and across other departments.
Provided hands-on direction for all aspects of the manufacturing of biologics, including vendor selection and process troubleshooting.
Drove successful outcomes on all manufacturing projects.
Shire HGT, Lexington and Cambridge, MA 2008-2010
Senior Engineer II, Manufacturing Technical Services - 2 years
Provided “on-the-floor” technical support in GMP bioreactor, roller bottle and media-buffer prep suites which included data collection and analysis as well as writing technical assessments for deviations.
Led a project which developed and implemented product wet filter integrity test parameters.
Represented MTS on a technology transfer team to start up cell culture production in a new “single-use” manufacturing facility.
Extended the hold time of dispensed raw materials from 24 hours to 7 days by leading a risk assessment team and authoring a technical report.
Collaborated with a team to perform the characterization (mixing studies, KLa) and “dry runs” of single-use bioreactors, holding tanks/bags and centrifuges.
Wyeth, (formerly American Home Products prior to 2002) Andover, MA 2000-2008
Senior Project Manager, Biotech Technology and Engineering - 2 years
Provided purification process subject matter expert support and technical support management for the start-up a GMP purification suite.
Facilitated a risk assessment of filter integrity testing which resulted in reducing filter integrity testing requirements for a commercial product.
Led technology transfer for a vaccine purification process suite start-up.
Served as co-leader of a manufacturing technology community of practice common interest group.
Manufacturing Manager Protein Purification, Multiple assignments - 6 years
Managed two successful suite “start-ups” and commercial manufacturing in production suites with staffs of 30-40 people.
Maintained the manufacturing schedule to meet business needs.
Managed teams to produce high quality and compliant products in a timely manner.
Represented my department during internal and external audits, regulatory audits and tours.
Led investigations for major process deviations.
Completed assignment as a protein purification subject matter expert at facility in Dublin, Ireland.
Ensured that all operations met cGMPs, training and safety requirements.
Interviewed and hired Shift Supervisors, Suite Coordinators and Technical Trainers.
Reviewed and approved batch records, SOPs, validation documents, etc.
Authored, reviewed and approved deviation reports, CAPAs and planned deviations.
Interacted with supporting departments including; HR, QA, QC, Validation, Engineering, Development.
ADDITIONAL PROFESSIONAL EXPERIENCE
American Home Products, (formerly Genetics Institute), Andover and Cambridge, MA 1994-2000
Associate Scientist, Pilot Lab and Cambridge Clinical Manufacturing Facility; collaborated on the start-up of a new clinical manufacturing facility, worked on development of purification and cell culture processes.
Production Supervisor, Clinical Manufacturing; coordinated the schedules and operation of all production activities in a protein purification suite, monitored all in-suite operations to ensure the quality and timeliness of cGMP production, interacted with supporting departments, FDA and other regulatory inspectors, wrote and reviewed documents, including batch records, SOPs, Manufacturing Formulation Records, IQs, OQs, and PQs.
Progression through development and manufacturing roles at Genetics Institute prior to 1994:
Senior Process Technician, Protein Purification, Clinical Manufacturing; performed all daily operations necessary to keep the protein purification suites operating. Performed column chromatography, UF/DF, and virus retention filtration. Wrote SOPs and batch records and responsible for in-suite supervision.
Development Associate, Process Technology Group; worked on development and scale up of fermentation, mammalian cell culture and purification processes. Supervised fermentation and isolation suite that produced product for Phase I Clinical Trial. Performed small and large-scale fermentation and mammalian cell culture, column. Chromatography, gel electrophoresis, Bradford protein assays, and UV spectroscopy.
EDUCATION and TRAINING
BS, Biology, Tulane University, New Orleans, LA
Continuing Professional Development:
- Principles and Techniques of Project Management (Boston University)
- Basic Statistical Process Control Workshop (WPI)
- Downstream Processing (MIT)
- Validation Issues in Chromatographic Processes (PDA)
- Tangential Flow Filtration for Pharmaceutical/Biotechnology (Millipore)