Experience

DSI - DS InPharmatics, a PLG company

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Head Of Project Management

  • May 2020 - Present



Prolong Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Head Of Operations

  • Mar 2019 - Feb 2020

  Leadership for Manufacturing, Process Development and Manufacturing Sciences(PDMS), Warehouse/Materials Management, Facilities, Metrology/Calibration, EHS - Environmental Health & Safety, and dotted line operational responsibility for Quality.

• Head Of Manufacturing

  • Apr 2017 - Mar 2019

  Head of manufacturing and supply chain operations.



Windtree Therapeutics

• Warrington, PA and Totowa, NJ

• Vice President, Manufacturing Operations

  • 2010 - May 2015

  Leadership and management of manufacturing operations, supply chain, technical support and medical device development (2010 - 2013) of our surfactant replacement therapy products and associated medical devices: - Instrumental in gaining FDA approval for the company's first specialty biotech product after many years and multiple complete response letters. - Modified key sterile processing routine to achieve process reliability and zero 483s on preapproval inspection of Totowa, NJ biotech manufacturing facility. - Replaced existing device engineering contractor with Battelle Memorial Institute for successful development and manufacture of the company's capillary aerosol generator for a critical phase 2 clinical trial of the drug/device combination product. - Collaborated with lyophilization consultant and co-inventor on patent to resolve manufacturing issue of key next generation biotech product. - Successfully executed tech transfer of sterile lyophilized process/product to contract manufacturing organization (CMO) for use in phase 2 clinical trials. - Identified contract engineering firm and initiated tech transfer to CMO for upcoming phase 3 clinical trial and commercial scale manufacturing of this next generation biotech product. Show less



Global Pharmaceutical Supply Group - Johnson & Johnson

• Horsham, PA

• Executive Director, Worldwide Manufacturing Administration

  • 2007 - 2009

  Represented Manufacturing on worldwide harmonization activities. - Facilitated and motivated a 12 member team (including 5 Plant Managers) on a project tasked with reducing network operational costs by 50% by 2012. Presented periodic updates to project review board. - Guided, reviewed and approved device design control documentation to develop novel drug/device auto-injector system resulting in the regulatory submission one week ahead of plan. - Member of worldwide change control board. Assessed all high-level technical change requests from worldwide plant network to ensure compliance with regulations and deadlines. Show less



Global Biologic Supply Chain (GBSC) - Johnson & Johnson

• Malvern, PA

• General Manager, Malvern Operations

  • 2006 - 2007

  Led a 400 person J&J bulk biologic production facility that achieved record production volumes and outstanding compliance for the manufacturing of a finished product that produced over $1 billion in sales: - Mentored Senior Director to lead the site through a significant business improvement initiative achieving geater than $10 million in cost reduction in 12 months and a site reorganization designed for achieving ongoing efficiencies and volume growth. - Mentored Senior Director to design and execute the on-budget and on-time completion of a $9.3 million 70,000 sq. ft. GMP warehouse renovation project. Show less



Global Biologic Supply Chain (GBSC) - Johnson & Johnson

• Horsham, PA

• General Manager, Contract Operations

  • 2004 - 2005

  Led a 19 person contract organization to procure and oversee a global sterile biotech fill/finish manufacturing network that provided a finished product with over $2.5 billion in annual sales: - As a board member of newly acquired J&J operating company, played key role in negotiating substantial settlements with suppliers of high value biologic drug substance that saved the company millions of dollars. - Finalized strategic plan and began executing a key project to identify and transfer appropriate 3rd party fill/finish volume to existing internal J&J sites to increase facility utilization, reduce costs, improve quality and compliance, increase control for critical high cost/high volume biotech products while balancing the need for business continuity assurance and cost. Show less



Pharmaceutical Sourcing Group Americas (PSGA) - Johnson & Johnson

• Raritan, NJ

• General Manager, Raritan Operations

  • 2001 - 2004

  Led a consolidation of a large pharmaceutical operation producing solids, semi-solids and liquids with the existing sterile biotech operation. Conceived, developed, managed and led a new 12 person site leadership team and 450 associates from two vastly different operations to achieve the highest performing pharma/bio manufacturing site for J&J in North and South America for three consecutive years based on the corporate scorecard: - Instilled a continuous improvement culture utilizing process excellence, lean manufacturing and six sigma methodologies. - Created a strategic vision and led the site leadership team to implement a plan focused on flawless execution achieving 99% line item fill rate (LIFR), 100% compliance metric, excellent safety and environmental record, 100% on-time product launches, greater than 10% reduction in MCI, and zero regrettable people losses and consistently led PSGA's plant network in overall performance. - Led the site transformation to a J&J pharma packaging center of excellence. Site sponsor for a $6+ million 36,000 sq. ft. pharma/bio packaging area upgrade project creating a state of the art highly automated cGMP packaging facility capable of handling a vast array of solid, liquid, semi-solid and sterile dosage forms and packaging configurations including controlled substances, vault and refrigerated storage. Show less



Ortho Biotech

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director, Raritan Biological Operations

  • 1997 - 2001

  Led a high achieving 85 person Biotech manufacturing and supply organization through a period of significant unit and $ volume growth achieving outstanding internal and external customer satisfaction. Managed through an extended period of key supplier delivery issues to ensure uninterrupted product supply supporting a $2+ billion business. Continued building reputation with FDA as a benchmark for internal aseptic manufacturing quality and compliance.

• Manager, Materials and Logistics

  • 1996 - 1997

  Developed a unifying vision and mission and consolidated the 67 person biotech manufacturing, production planning, MRP purchasing and package development functions into one department that resulted in flawless execution and uncompromised quality and compliance.

• Facility Manager, Biological Manufacturing

  • 1993 - 1996

  Led cross-functional team of approximately 60 site employees and 60 operating company associates to bring the aseptic biotech facility in compliance with FDA regulations by responding to "the 55 item 483" including restructuring the organization, overhauling the plant policies and procedures and leading a cultural change. The Warning Letter was lifted after 6 months with no interruption of product supply and FDA ultimately used the site as a benchmark for compliance.- Initiated and developed a strong partnership with the Site Quality Head and together modeled the foundational behaviors of effective communication, mutual trust, respect and teamwork between Operations and Quality that ultimately improved productivity, quality and morale. Show less

• Product Planner/Buyer

  • 1991 - 1993

  Refined the MRP purchasing process for the recombinant DNA derived erythropoietin (EPO) plant in Puerto Rico to effectively manage over $5 million in purchasing per year.- Identified and gained J&J approval for a 3rd party aseptic fill/finish CMO. Led a cross functional team in the biotech tech transfer. Wrote the Manufacturing part of the M&C (Manufacturing and Control) section of the regulatory submission which was subsequently approved by FDA.- Managed worldwide production planning for one of J&J's flagship bulk biologic products that produced revenues of over $1 billion annually.- Developed and negotiated a long-term supply agreement with a major supplier to manufacture PROCRIT, a product that grew to annual sales of over $2.5 billion. Show less



The Janssen Pharmaceutical Companies of Johnson & Johnson

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Supervisor/Senior Supervisor, Biological Manufacturing

  • 1989 - 1991

  Supervised 9 associates in the formulation, sterile filling, inspection, labeling and packaging of the first therapeutic monoclonal antibody approved by CBER/FDA for human use - Managed projects and coordinated technology transfers of new products from research to operations. Supervised 9 associates in the formulation, sterile filling, inspection, labeling and packaging of the first therapeutic monoclonal antibody approved by CBER/FDA for human use - Managed projects and coordinated technology transfers of new products from research to operations.



The Liposome Company

• Biotechnology Research

• Research Scientist, Pilot Plant

  • 1987 - 1989



Ortho Pharmaceutical Inc. - Johnson & Johnson

• Raritan, NJ

• Research Assistant

  • 1986 - 1987



Elkins Sinn Inc.

• Cherry Hill, NJ

• Research Assistant/Supervisor Sterile Operations

  • 1984 - 1986