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.
• Extensive experience interacting with the FDA and other regulatory agencies through site
inspections, and submissions and responses to submissions.
• Strong experience in a wide assortment of manufacturing processes (including extensive
aseptic manufacturing experience), drug presentations, manufacturing equipment and
analytical methods.
• Excellent communication skills including reporting to, and coordination with, site and global
leadership.
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 Directly responsible for the Prevnar 13®
aseptic Syringe and Vial filling lines,
including filling operations, inspection, process improvement, regulatory
submissions, and investigation support.
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 the Clean in Place (CIP) process for Prevnar 13®
formulations resulting in
40% reduction in cycle time. Led a multifunctional team including technical services,
manufacturing, quality and training.
o Optimized target fill weight for Prevnar 13®
aseptic vial filling line – Resulting in 7%
increase in yield.
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 SECONDMENT (2015 – 2016) - Responsible for managing the Pfizer Quality
Standard revision process, including development, global review and response, final
draft, approval, Training and Compliance Analysis Standard (CAS) development.

2. Anthony Polomene (continued)
• 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
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
• Author: “Container Closure Integrity Control vs 100% Integrity Testing During Routine
Manufacturing,” PDA Journal, May/June 2015
• Presenter – PDA Annual Conference, Container Closure Integrity Testing Interest Group,
March 2016, “Container Closure Integrity Control”
• Presenter – Risk Based Approaches to Setting Cleaning Validation Acceptance Limits
• Pfizer Pfizer Mission Award, “Prevnar 13®
Quad Drum Fill”, Pfizer Mission Award,
“Pearl River – Investigations Workload Reduction,” 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,” W.E. Upjohn Award,
“Pfizer/Hospira integration CAS review”
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
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