Industry Consultant


Pharmaceutical executive with over 30 years of diversified experience in engineering, operations, validation, supply chain and quality systems.  Proven ability to meet aggressive timelines.  Excellent skills in project management, validation, quality system development and facility renovations/start-ups.



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.

    • Provided project management for fast track design/construction and qualification/validation drive. First demonstration batch initiated on the eleventh month.
    • Successfully completed three FDA inspections with zero observations. 
    • Designed quality systems for the site. 
    • Coordinated tech transfers for 10 products including coordination of process validation and cleaning validation.
    • Developed a five year strategic production plan to accurately define capacity and equipment needs.  Re-designed facility to meet projected capacity needs which doubled the facility size. 
  • 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.


Adelphi University, Garden City, NY.

M.B.A. Finance, 1986

New Jersey Institute of Technology, Newark, NJ.

B.S. Mechanical Engineering, 1979

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