Anthony Polomene
20 Elmira Ave, Staten Island, New York 10314
(732) 693-9371
tonypolomene@gmail.com
Profile
• Manager of B...
Anthony Polomene (continued)
manufacturing operations, quality operations and training. Responsibilities included
process ...
Anthony Polomene (continued)
Education
BS Chemistry, State University College, Fredonia, New York, May 1992
MS Education, ...
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Polomene Resume April 2015

Published on: Mar 4, 2016
Source: www.slideshare.net


Transcripts - Polomene Resume April 2015

  • 1. Anthony Polomene 20 Elmira Ave, Staten Island, New York 10314 (732) 693-9371 tonypolomene@gmail.com Profile • Manager of BioPharmaceutical Technical Services with 20 years’ experience in manufacturing process development, process improvement, transfer, and validation. • Leader of numerous, successful, complex process improvement projects involving the coordination of multiple departments, sites, and levels of management. • Strong experience in a wide assortment of manufacturing processes (including extensive aseptic manufacturing experience), drug presentations, manufacturing equipment and analytical methods. • Extensive experience interacting with the FDA and other regulatory agencies through site inspections, and submissions and responses to submissions. • Excellent communication skills including reporting to, and coordination with, site leadership. Technical Summary • Skills o Process Development and Validation o Aseptic Operations including Isolator Systems, RABs o Syringe Filling / Vial Filling o Formulations (parenterals, dry powder, liquids, ointments creams) o Visual Inspection Systems o Tableting / Tablet Coating Systems o Packaging / Container Closures o Environmental Monitoring o Media Simulation o API Manufacturing (Vaccines, consumer products) o GMP Audit and Regulatory Inspection • Drug Presentations o Vaccines (API, product) o Tablets (API and product) o Small Molecule o Consumer products o Biological products o Tissue products o Liquids, Ointments, Creams Career Summary • 2006-Present: Manager Technical Services – Pfizer, Pearl River, New York Responsible for the development, validation and troubleshooting of manufacturing processes, environments and equipment in the filling, formulations and API manufacturing areas. o Optimized the Clean in Place (CIP) process for Prevnar 13® formulations resulting in 40% reduction in cycle time. Led a multifunctional team including technical services,
  • 2. Anthony Polomene (continued) manufacturing operations, quality operations and training. Responsibilities included process development, validation, and implementation of procedures. o Developed innovative Container Closure Integrity testing method using Helium Leak for Prevnar 13® pre-filled syringes. Led a team including contract testing labs, site technical services, manufacturing operations and quality operations. o Pfizer L3 Team Leader for the BioPhorum Operations Group (BPOG) CCIT Workstream. Responsibilities include managing Pfizer contribution and feedback to workstream discussions and publications, managing Pfizer global network input and reporting to Pfizer leadership. o Hoshin Team Leader “Reduction of Manufacturing Investigations” – Coordination of all site Manufacturing Operations Units for the reduction of events classified as Quality Assurance Reports by 32%. o Optimized target fill weight for Prevnar 13® aseptic vial filling line – Resulting in 7% increase in yield. o Developed processes and equipment for a new formulation suite for Prevnar 13® resulting in doubled batch throughput. o Managed the Wyeth Consent Decree remediation for cleaning validation of Prevnar® Polysaccharide manufacturing under considerable time and budget constraints. • 2002-2005: Senior Validation Scientist – Schering-Plough, Kenilworth, NJ Responsible for the development, validation and troubleshooting of manufacturing processes and equipment in formulations and API manufacturing areas. o Developed and validated Clean in Place (CIP) procedures for Drixoral tablet manufacturing and coating equipment resulting in reduced cleaning cycle times by 50%. o Developed and validated Cleaning processes for Drixoral Wet Formulation tableting and coating equipment. • 1998-2002: Validation Scientist – Day And Zimmerman, Philadelphia, PA Validation and Development Consultant o Schering-Plough, Kenilworth, NJ – Consent Decree remediation of processes and equipment – Commercial drug product and API Manufacturing. o Centicor, Malvern, PA –Analytical methods development and validation – Vaccines drug products. o Biopure, Cambridge, MA – Analytical methods development and cleaning validation – Biological products. • 1994-1998: Osteotech, Shrewsbury, NJ Validation Specialist o Packaging Development and Validation, Cleaning Validation (Tissue Processing). 2
  • 3. Anthony Polomene (continued) Education BS Chemistry, State University College, Fredonia, New York, May 1992 MS Education, Wagner College, Staten Island, New York, Pending (30 of 39 credits), 3.96 GPA Awards, Publications and Presentations • “Container Closure Integrity Control vs 100% Integrity Testing During Routine Manufacturing,” PDA Journal, May/June 2015 • Presentation – Risk Based Approaches to Setting Cleaning Validation Acceptance Limits • Pfizer Mission Award, “Prevnar 13® Quad Drum Fill” • Pfizer Pearl River PGM Technology and Innovation Award, 2010, “Prevnar 13® Optimization Project” • Pfizer Globe Award, 2011, “13v Recipe Optimization Project” • Pfizer North American / Pearl River Engineering Award, “Building 250 Isolator Vial Line Project” Memberships / Professional Affiliations Bioprocess Operations Group (BPOG): Container Closure Workstream (L3 Lead) • Parenteral Drug Association • International Society for Pharmaceutical Engineering (ISPE) References Available upon Request 3

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