--- title: 040 description: A consultant with The FDA Group. --- [The FDA Group's Consultant Finder ](https://www.thefdagroup.com/find-consultants) # [040](https://www.thefdagroup.com/find-consultants/40) Written by [The FDA Group](https://www.thefdagroup.com/find-consultants/author/the-fda-group) | Jul 12, 2022 6:54:41 AM **HIGHLIGHTS**   ***Vero Biotech*** - **2019 (3 months)** - Authored Facility VMP with Risk Based AHU assessment (classified as indirect equipment)*** *** - Authored EMS computer validation plan  - Managed EMS Qualification (direct impact) including vendor management of system qualification.  Selected vendor, conducted vendor audit, managed protocol development.  Executed EMS protocol in 2 weeks.   **Immunomedics – 2018** - Installed back up Clean Steam Generator - Installed back up WFI Still - Installed and managed Qualification of Autoclave - Installed and managed Qualification of Parts Washer - Designed, installed, qualified Ambient WFI System - Installed and managed qualification of EMS system (T, RH, DP) - Desiged ad qualified 10,000 SF Warehouse including ISO 8 Sampling Suite   **Akorn – 2016-2017** - Designed, Built, Qualified 22,000SF Chemistry and Tech Support Labs - Designed, Built, Qualified 15,000SF Microbiology Labs - Designed 60,000SF Chemistry and Micro Lab Facility (different location)   ***Other key projects (various clients) - 2001-Present*** - Project Manager for $35M aseptic facility renovation (3 suites and 7 Lyo’s) including design, construction and qualification. Developed bid scope for A/E firm and awarded project, managed program design, developed project schedules and coordinated client resources to design, build, install equipment and qualify facility.  Designed 2 RABS systems for existing fill equipment.  Conducted smoke studies to confirm mock up designs.  Scope also included environmental PQ, media simulation and product transfer plans. - Completed a $10M Aseptic Filling Facility Renovation (Conceptual design, production design and construction), authored VMP and developed qualification schedule.  Corrected cGMP deficiencies in A/E firm design and modified design to allow concurrent manufacturing during renovation.  Designed RABS systems for existing and new fill equipment. - Developed and lead a team to design and qualify a biotech production suite upgrade for cGMP compliance (new product conversion including CIP and SIP upgrades) and replace computer control system including software validation. - Redesigned client modular clean room for improvements in personnel and material flow.  Developed approach for single use buffer bags for connection to filling line.  - Led four project teams in design, construction, validation, SOP development and maintenance process to complete construction of an aseptic filling area.  Validation included a RABS based 400vpm filling line, utility systems and component preparation process.   - Led Client Team in conceptual design and fast track into production design for an aseptic formulation suite.  Qualified suite for production use including media simulations. - Led SOP team at client site to improve SOP quality and reduce cycle time (150 SOPs) to meet 2 year review cycle commitment.  The production group had the highest SOP count and was the first to meet the CD review goal. - Led three project teams in validation, SOP development and component supply to meet CD commitments.  Designed an interactive SOP approval process and developed a component release plan for clinical supply materials. - Reviewed client validation documents to ensure compliance with CD commitments (equipment, process and cleaning. - Developed client site validation master plans and cleaning validation master plans *** *** ***AVENTIS PASTEUR, INC., ****Swiftwater, PA *                           **1999 - 2001** ***Director of Filling & Packaging***  Responsibilities include operations and technical/engineering support for an aseptic finishing facility. Accountable for finishing $450M in vaccines with an operating budget of $14M and a headcount of 175 employees. - Completed conceptual designs for a new Aseptic Formulation and Fill/Finish Facility  Developed 3 different conceptual designs to meet various funding strategies and forecasts.  Developed capacity plans and fill technology assessments for BODs. - Developed area re-validation strategy (existing facility) and led plan to improve area validation compliance profile. - Complete design, construction and qualification of a $1.7M area expansion to improve cGMP compliance (workflows) and enhance capacity. - Commercialized vial-filling line using full barrier isolation technology.  This line was the first barrier line licensed for biologic production in the U.S. - Developed system to reduce investigation report cycle time from 90+ day average to under 20 days. - Led SOP review process to bring review cycle time within 2 years. - Process Leader to commercialize novel auto injector technology and supporting clinical trials.   ***BARR LABORATORIES, INC., Forest, VA*** ***        *** ***       *** **1996 - 1998** ***Director of Manufacturing *** Responsible for the design, construction, validation, and start-up of a new $35M solid dosage high containment production facility.  Other key responsibilities included staffing, training, SOP development, and commercialization of a computerized inventory control system.  Annual operating budget of $10M. - Designed and installed new high containment processing and packaging equipment***.***   ***DUPONT PHARMACEUTICAL COMPANY, ****Garden City, NY*                                       **1980 – 1996** ***Director of Manufacturing ***(**1994 – 1996)**      Responsible for warehousing, manufacturing (including **CII-CIII** products), packaging and maintenance operations.  Accountable for managing $50M in variable costs and an operating budget of $4M with a headcount of 100 employees.   - Successfully launched five new products, which doubled the output of the facility.   - Reduced variable costs by 15% by implementing team based concepts and re-engineering work flows.   - Commercialized a high speed packaging line for a new product launch. - Reduced product cycle times from an average of 45 days to 15 days.   ***Director of Engineering/Technical Services (1993 – 1994)*** Provided product support, validation (equipment, process, cleaning), engineering, and maintenance services to the Garden City, NY site.    - Developed commercialization plans for four new products.   - Led a cross-functional, multi-level process improvement team which re-engineering the site’s workflow/systems to reduce cycle time and improve quality.      ***Manager of Contract Mfg & Engineering (1991 – 1993)*** Responsible for contract manufacturing sourcing, engineering, and maintenance.  Managed contract relationships with third party manufacturers, which included auditing, negotiation, and supply issues.   - Completed design, construction and start-up of $12M major facility renovation, which required a total site shutdown of 4.5 months including qualification.  This major project was completed on time and within budget and allowed the site to resume production in a fully renovated facility without a product stock-out.   ***Project Manager**** - Wilmington, DE ****(1989 – 1991*****)** Responsible for managing the design, construction, qualification and commercialization of a new $27M vivarium facility for R&D use.  This project was completed on time and $3M under budget. **EDUCATION** **Adelphi University**, Garden City, NY. M.B.A. Finance, 1986 **New Jersey Institute of Technology**, Newark, NJ. B.S. Mechanical Engineering, 1979 [View full post](https://www.thefdagroup.com/find-consultants/40) ```json { "@context" : "http://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "The FDA Group" }, "dateModified" : "2022-07-12T06:54:41.210Z", "datePublished" : "2022-07-12T06:54:41Z", "headline" : "Industry Consultant", "image" : { "@type" : "ImageObject", "height" : 60, "url" : "/hs/hsstatic/content_shared_assets/static-1.4092/img/default-amp-logo.png", "width" : 60 }, "mainEntityOfPage" : "https://www.thefdagroup.com/find-consultants/40", "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "height" : 60, "url" : "/hs/hsstatic/content_shared_assets/static-1.4092/img/default-amp-logo.png", "width" : 60 }, "name" : "The FDA Group's Consultant Finder" } } ```