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