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H. LAVAL HARLEY
Principal Scientist with extensive experience in solving Pharmaceutical processing and Medical Device concerns related to manufacturing process and development. Wide background in pharmaceutical operations: with a proven track record in process / technical development, manufacturing, validation, research and development, manufacturing process site to site transfer. Manufacturing Processing changes include: material and equipment interface, raw material concerns, material site to site transfer, equipment modification / replacement and process qualification / validation AREA OF EXPERTISE
 Development and Scale up  Project Management PROFESSIONAL EXPERIENCE

CORDIS CORPORATION (J&J Company), Miami Lakes, FL
2005 - 2009
Principal Scientist (2007 - 2009)
Subject Matter Expert “SME” for component materials that resulted in the interaction with functional
areas that include: Regulatory Affairs, Production Operations, Sustaining Engineering, Quality Control,
Quality Assurance, Legal, Sourcing, Purchasing, Packaging, Sterilization and Suppliers. Supplied
expertise that would support the continuity of the manufacturing process and prevent production
interruptions. Highlights of 2009 include:
 Led team that qualified Rilsan® with Tungsten to prevent production interruption after supplier
changed size of compounding extruder- $14mm/yr cost of goods and services.  Led Monthly Technical Limited Supply Materials meeting to provide transparency into status of limited supply materials and continued to prevent production interruptions from January through December 2009.  Conducted four product qualification justification assessments.
 Successfully completed green belt training for 6 sigma.
Principal Engineer (2005 - 2007)
Primary participant in executing shelf-life extension project for Cypher in San German, Puerto Rico.
Assisted in project planning and provided expertise for projects report documentation. Supported
production equipment revalidation by reviewing and approving documentation. Highlights are:
 Nitrogen Flow Measurements in Module 4 Spray Coating Carts prior to flow meters installation.
 Performance Qualification Report (PQ) of the Enhanced Spray Coating and work in process (WIP)

HOFFMANN-LA ROCHE, Nutley, NJ
1970 - 2005
Manager Technical Operation “3rd Party” (2000 - 2005)
Project Manager providing technical guidance for technical transfer of all galenical products sold in US.
Provided project management for individual products and monitored third party manufacturing operations
in support of high quality product development / scale up and technical support and efficient, cost
effective Technical Development Operations.
H. LAVAL HARLEY
 Successfully pasted all third party FDA inspections that resulted in no citations.  Completed transfers within budget and time line.  Resolved project yield issue that was caused by defective semi-solid capsule equipment process that  Resolved lyophilization issue for third party manufacturing located in Rochester, Michigan and
Principal Investigator, Pharmaceutical Process and Technical Development (1994 - 1999)
Managed scale up of manufacturing processes from development to production size batches and
equipment. Coordinated change with required function groups such as Production Operations, Drug
Regulatory Affairs, Distribution, Quality Assurance, Marketing, Quality Control, Planning, Purchasing
and Packaging.
 Timely completion of scale up to meet product launch schedule.
 Developed and implemented new manufacturing technologies into Manufacturing Factories, for  Resolved production issues by trouble shooting production problems in Humacao and Manati, Puerto
Senior Engineer, Pharmaceutical Tablets, Liquids Semi-Solids and Capsules (1990 - 1994)
Supervised team of two professional and eight operators. Met production schedule as required. Conducted
training for changes in manufacturing processes. Demonstrated the manufacturing process was conducted
as per Current Good manufacturing Process “cGMP”.
 Transferred Packaging line from Montréal, Canada to Nutley, NJ and successfully performed all
IQ/OQ and Product Performance Qualification for tablet and capsule line.  Completed Installation Qualification / Operation Qualification (IQ/OQ) for 100% of installed equipment associated with plan products. Completed IQ/OQ for 98% of installed equipment in Process and Technical Development and 85% of the major installed equipment in TLC production.  Reduced equipment down time by 20% through training operators to perform routine maintenance on equipment instead for waiting for the mechanic.
Previous Experience and Selective Highlights (Includes Hoffmann-La Roche) (1969 - 1990)
Assistant Manager, assigned to Pharmaceutical Process and Technical Development (1990) 
 Project Managed interface activities for Demadex Product line transfer from Boehringer, Mannheim,
Germany to Roche, Nutley. This included financial, legal, drug regulatory affairs, planning, sales and
marketing interaction, distribution, production, package development, process development, purchasing,
and quality control management requirements for transfer. Product line consisted of Demadex Tablets
5mg, 10mg, 20mg, and 100mg - Demadex ampoules 2 ml and 5 ml.
Assistant Manager, Sterile and Liquid Products Production (1980 - 1989)
 Technical representative for Vendor Certification Traveling Team that qualified suppliers in US,
Belgium, France, Germany, Spain, Italy and Switzerland.
Senior Group Leader, Diagnostic Production (1977 - 1980)
 Responsible for manufacturing process for all drug kit testing and cancer test products, sales total

Senior Scientist, Diagnostic Process Development (1975 - 1977)
 Developed process and published Red Conner Report which introduced manufacturing change that
H. LAVAL HARLEY

Scientist, Diagnostic Research and Development (1972 - 1975)
 Participated in six month development program in Marketing Research Department and Roche
Assistant Scientist, Q C Analytical Research (1971 - 1972)
 Successfully completed six alternate material source projects for pharmaceutical active ingredients

Analyst, QC Raw Material, Bulk and Finish Dosage (1970 - 1971)
 Performed various analytical testing required to demonstrate that raw materials were acceptable for
use in manufacturing process of pharmaceutical products. EDUCATION
MBA, Business Management
Fairleigh Dickinson University, East Rutherford, NJ Bachelor of Science (BS), Chemistry
Johnson C. Smith University, Charlotte, NC

Source: http://www.qbdauditing.com/documents/LHarleyCV.pdf

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