040

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.

• 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.

EDUCATION

Adelphi University, Garden City, NY.

M.B.A. Finance, 1986

New Jersey Institute of Technology, Newark, NJ.

B.S. Mechanical Engineering, 1979