Eugene J. McNally, Ph.D.

BACKGROUND SUMMARY 

A Senior Pharmaceutical Scientist and Executive with extensive experience in both small molecule NCE and large molecule protein drug development who knows how to build and run a business.  Leader with a unique blend of people management and technical skills who is highly successful in managing cross-functional drug development teams. 

PROFESSIONAL EXPERIENCE

PHARMA DEVELOPMENT CONCEPTS, LLC                      Madison, Wisconsin   2007 - Present
A product development consulting business
Pharmaceutical Development Consultant
Drug Development Stratagies                                       CMO Management         High Potency Drugs

GALA BIOTECH, a Catalent Pharma Solutions Company Middleton, WI       2006 - 2007
(Formerly Cardinal Health, Inc.)
A $12 million biologics API development business
Vice President and General Manager    
•    Directed a site of 60 biotech development and clinical             manufacturing scientists
•    Responsible for Quality Assurance, Quality Control,                 Regulatory, Development, Engineering, Operations and         Project Management groups
•    Worked with sales group to attract and close new drug         substance development business
•    Provided strategic development advise to clients
•    Introduced Lean Six Sigma tools to optimize cell                     culture/feeding processes that resulted in a 200%             increase in protein titers using a proprietary                         retrovector expression system

CARDINAL HEALTH, INC.                                     Somerset, NJ                                            2002 – 2006
A $45 million oral product drug development and manufacturing business
Vice President of Research and Development  (2005- 2006)
•    Responsible for Formulation and Analytical development         staff of 100+ scientists
•    Directed $5M high margin commercial analytical release         testing operation
•    Worked with Sales group to attract and close new drug         product development business
•    Seamlessly transfered new drug products to commercial         plants for launch; two to four per year
•    Developed intellectual property to expand oral drug             delivery portfolio which resulted in high value long             term development contracts
•    Directed site Environmental Health and Safety group             responsible for potent drug handling that accounted for         40% of site business
•    Implemented a Data Review Metrics Program within             Analytical Sciences Department that reduced notebook         and CoA errors by greater than 70% in three months,         and forced resolution of analyst/QA notebook disputes
•    Sponsored a Kaizen event to optimize layout of                     laboratory instruments, chemicals and supplies that              resulted in a savings of one hour per day per analyst
 
Vice President of Development Operations    2004 - 2005
•    Responsible for daily operation of an $85M state of the         art drug development and manufacturing facility with a         staff of 45+ professional and hourly employees
•    Recruited experienced management team to run Pilot             Plant, Engineering, Validation, Facilities, and                         Warehouse/Logistics groups
•    Obtained FDA approval to manufacture first commercial         product in Somerset plant with no 483 observations
•    Invented, designed, fabricated and installed a novel             containment conveyance system for processing highly         potent drugs that resulted in millions of dollars of new         business
•    Implemented an On Time Delivery (OTD) metrics system         that maximized throughput of Pilot Plant manufacturing         operation; resulted in a 95% on time start for batch             production
•    Instituted a gainsharing program that rewarded hourly         operators for attaining OTD metrics, quality metrics             and process improvement goals
Director of Pharmaceutics     2002 - 2004
•    Established a preformulation group and recruited                 experienced scientists; produced first year revenues in         excess of one million dollars
•    Reorganized solid dosage formulation group and quickly         landed revenue generating projects
•    Established a value proposition of sound drug                         development operating principles

BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. Ridgefield, CT                                          1989 - 2002
A Research based major pharmaceutical company

•    Directed progress of scientific work in Pulmonary, Solids,             Liquids, and Softgel formulation groups
•    Served as the Pharmaceutical Expert for Late Stage NCE             Development Projects
•    R&D Project Team leader; developed line extension and             combination products for AIDS drugs
•    Simultaneously performed duties of Laboratory                         Supervisor for small molecule formulation laboratory
•    Developed and implemented strategy for outsourcing                 formulation development and production of clinical trial             materials for highly potent drugs

Senior Scientist/Principle Scientist/Senior Principal Scientist, Department  of Pharmaceutics
•    Responsible for preformulation, formulation, analytical                 method development, sterile filling (solution and                     lyophilized products) and drug delivery experiments for             biological products
•    Preclinical Project Team Leader; led projects to                         successful IND filing.
•    Founded and ran a drug discovery support group                         responsible for cell culture and purification of proteins             to support discovery target assays and high                             throughput screens
•    Contributor to ten IND filings and five NDA filings for new             molecular entities
•    Responsible for technical transfer of processes and l                 methods to Boehringer’s commercial GMP production                 facilities in Europe
•    Developed techniques to pegylate antibodies including                 processing schemes to minimize loss of biological                     activity

EDUCATION

Ph.D. in Pharmacy (Pharmaceutics)                        University of Wisconsin - Madison,  Madison,WI
M.S. in Pharmacy (Pharmaceutics)                           University of Wisconsin - Madison,  Madison, WI
B.S. in Pharmacy                                                       Duquesne University, Pittsburgh, PA