Expert Details

Expert in Process Engineering; Project Management-PRINCE2; Process Excellence; Pharma Solid Dosage scale-up

Expert ID: 723761 New Jersey, USA

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My diverse background includes:

. 16+ years of executive management experience with Pharmaceutical and Consumer goods companies such as, Abbott, Pfizer Inc.
Bristol-Myers Squibb, Johnson & Johnson, and Procter & Gamble.
• Over 10 years experience in Pharmaceutical Development, Engineering and Technology (Lab Automation, Information Technology and
Business Intelligence).
. Helped design largest privately funded Pharmaceutical Clinical research Organization, and Global R&D Informatics organization in a
difficult, post-merger restructuring period.
. Helped create business opportunities for faster execution of clinical studies that used CROs and globally deployed company resources
• 4 years experience starting up a new eSubmissions function (publishing eCTDs) and implementing an eArchiving strategy for R&D &
Scientific records.
• 8 years experience supporting new business relationships (Licensing and Alliances) for Pharmaceutical business development.
. Directed multi-million dollar technology transfers, and scale-up of new ethical and OTC products (solids and liquids) from R&D to
manufacturing (including contract manufacturing).
• Refocused Clinical Research Systems group to develop and implement new electronic-data-capture and web-based clinical investigator
monitoring/tracking applications globally. This allowed the redirection over $2 million in potential clinical studies expenses, and reduced
cycle times of six clinical studies by more than 3 months each.
. Implemented Lean Manufacturing processes (Pharmaceutical process/packaging lines) that reduced waste by 30%, increased line
output by 60%, and reduced staff by 9%.
. Background includes knowledge and technical support of all phases of life cycle management for pharmaceutical products in drug
Discovery, Development Sciences, Clinical Research and Manufacturing, Marketing and Sales.
• Directed contractors and suppliers of major services for the construction and commissioning of a new pharmaceutical plant


Expert may consult nationally and internationally, and is also local to the following cities: New York, New York - Yonkers, New York - Newark, New Jersey - Jersey City, New Jersey - Paterson, New Jersey - Elizabeth, New Jersey - Bridgeport, Connecticut - Stamford, Connecticut - Philadelphia, Pennsylvania - Allentown, Pennsylvania

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Education

Year Degree Subject Institution
Year: 1975 Degree: BS Subject: Mechanical Engineering Institution: New Jersey Institute of Technology

Work History

Years Employer Title Department Responsibilities
Years: 2007 to 2011 Employer: Undisclosed Title: Associate Director Department: Undisclosed Responsibilities: Process Improvement
• Directed team of highly skilled records management professionals and eliminated large volume of digital correspondence from archiving backlog.
• Served as an expert lead in monitoring and assessing process and systems that support due diligence, litigations and R&D.
Program and Project Management
• Managed the electronic Report and e-Submission publishing staff, operations activities and the upgrades of 7 versions of eCTDXpress.
• Used my business/IT experience and ability to get IT to understand the Regulatory client mindset and assessed the impact to the business of any regulatory change surrounding the creation of electronic submissions worldwide, and the delivery of good records management globally.
• Supported Director as needed to assure business followed global regulatory standards (OECD, OAIS and GXP) for cataloging and archiving all proprietary information and understanding both the process and technical challenges using Documentum to complement the existing records archive.
Resource/Cost Control Management
• Line managed submissions Publisher group (13 staff) across multiple therapy areas and concurrent projects to deliver over 60 electronic submissions (eCTDs) a month.
• Using Planisware 5, MS Project assured resources and capacities were available and fully utilized to consistently meet required electronic and paper publishing schedules.
Years: 1999 to 2003 Employer: Pfizer Inc. Title: Undisclosed Department: Global R&D Responsibilities: Responsible for mobilizing talents of staff, who evaluate, develop and deliver Informatics strategies for building world-class platforms and lean R&D processes that support scientific Discovery and Development. Ensured full delivery of business requirements gathered to address global objectives. Led development and implementation of policies for staff recruitment and development. Developed and mentored leaders for Centers of Excellence and Communities of Practice. Implemented local compensation policies, performance evaluation, rewards and recognition systems.
Years: 1984 to 1999 Employer: Undisclosed Title: Snr Manager Process Engineering & Project Engineering Department: Undisclosed Responsibilities: Directed division-wide programs for Responsible for all Process Engineering, Process Development and new process Validation and Stability programs. Led cross-functional teams for new product introductions.
Years: 1982 to 1984 Employer: Johnson & Johnson Title: Undisclosed Department: International Operations Responsibilities: Responsible for all Facilities, Production, Warehousing and Distribution Operations
Years: 1975 to 1982 Employer: Procter & Gamble Title: Undisclosed Department: Undisclosed Responsibilities: Responsible for Oil Refinery Operations, Quality Assurance for vegetible oil hardening & deodorizing operations

International Experience

Years Country / Region Summary
Years: 1982 to 1984 Country / Region: Trinidad & Tobago Summary: Johnson & Johnson. Comissioned new manufacturing facilities and was responsible for all Production, Warehousing and Distribution Operations

Additional Experience

Training / Seminars
• Deployed leading edge Clinical Data Management system assuring rapid globalization of clinical studies.
Marketing Experience
• Helped Pharmaceutical archive management to recognize the shortcomings in the archival of electronic submissions and led a new product evaluation initiative (e.g. alternatives included Autonomy, Documentum+Sharepoint versus custom-build).
• Enhanced the scientific archive capacity by using Documentum (with FirstDocs) for handling over 750K records (19 million images), developed e-Archiving single repository proof-of-concept, and strategy for implementation, startup and post-startup activities.
Other Relevant Experience
• Streamlined R&D processes resulting in execution 40% more drug licensing alliances and agreements with no increase in staff.
• Shortened the cycle-time while adhering to GXP and GAMP programs, for R&D processes by 60% by implementing Value Engineering in Lab Automation, document management process optimization and pre-formulation development.
• Led development of 6 new product introductions in one year, including one that generated $50 million sales in year two
• Led Process Improvement initiatives that realized a 30% increase in line output, and reduced waste by 60%.
• Managed introduction of several new products that realized over $35 million in division’s increased annual sales.
Certified in PRINCE2 Foundation project management methodology

Fields of Expertise

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