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Bio-Pharmaceutical Process Analytical Technology Expert

Technical Consultant #2078


Expertise

  • Process analytics in process manufacturing, research and development.
  • Evaluation, installation and implementation of process analytics (PAT).
  • Development of process analytics and PAT support teams.
  • Online analyzers for industrial health and safety applications.
  • Evaluate, identify, implement online analyzers for environmental discharge monitoring.
  • Assist pharmaceutical/biopharmaceutical industry with establishment of PAT programs.
  • Process analyzer qualification and validation.
  • Process analytics sampling system design, development, implementation.
  • Marketing materials for pharma/biopharma process analytics products.
  • Product and market identification of pharma/biopharma process analytics products.
  • Product engineering design for online HPLC/UHPLC/UPLC (Liquid Chromatography) products.
  • Training end-users on uses and advantages of process analytics and PAT.
  • Online HPLC/UHPLC/UPLC (Liquid Chromatography).

Experience

Independent Consultant, 2001 - Present

  • Assist pharma-biopharmaceutical industry customers evaluate and apply PAT (Process Analytical Technology).
  • Evaluate possible PAT applications in process research and development manufacturing.
  • Assist with development of PAT project and support teams.
  • Design process sampling interfaces.
  • Training on process analytics applications and their potential benefits.
  • Assist instrument companies with development of process analytics markets; particularly in the pharma/biopharma industry.

Dionex Corporation, 2005 - 2011

Corporate Marketing, 2008 - 2011

  • Developed print and e-media marketing materials for support of the process analytics product line.
  • Assist the sales organization with identification of business opportunities and developing these into sales.
  • Generate process analytics market development plan.
  • Worked with product engineering to re-design the on-line HPLC product. Key contributor to modular product design, adaptable to applications from the process development lab to full-scale production.
  • Design recognized by Frost & Sullivan with chromatograph product of the year award.

Process Analytics Center of Excellence, 2005 - 2008

  • Lead development and implementation of the corporate strategy for process analytics. Provide technical assistance to the sales organization.
  • Develop marketing and lifecycle plans for current and future process analytics products.
  • Develop partnerships with key customers, vendors, and academic research groups necessary to deliver the strategic plan.
  • Collaborated with customers and 3rd party vendors to develop customized sampling and application solutions for customers.

Eli Lilly and Company, Team Leader, 1972 - 2005

Team Leader/Sr. Research Scientist, Process Analytical Measurement Technology

Manufacturing Science - Technology, 2003 - 2005

  • Provided technical leadership and mentoring, recruiting, business and budget planning as the Team Leader of the Process Analytical Measurement Technology group of the corporate PAT strategy plan.
  • Delivered corporate-wide leadership and planning for PAT implementation with dotted line reporting to the VP of Manufacturing Science and Technology.

Technical Contributor, Measurement Technology Group, Engineering Technology Center, 1996 - 2002

  • Designed, developed, and supervised the installation of process and environmental analyzers in production facilities worldwide via collaboration with engineers and scientists at the sites.
  • Identified and developed a collaborative relationship with a commercial chromatography instrumentation vendor to provide off-the-shelf on-line HPLC solutions.
  • Utilized in future installations in place of the in-house built systems previously used.
  • Assisted QC laboratories to increase efficiency through the use of automation.
  • Provide technical leadership and mentoring, as well as, business and budget planning to the measurement technology self-directed work team.

Biosynthetic Human Insulin (BHI) - Development

Process Automation, and Process Engineering Departments, Bulk Operations

  • Designed, developed, and supervised the installation of process and environmental analyzers in biosynthetic production facilities in Indianapolis and Liverpool, U.K. via collaboration with engineers and scientists.
  • Co-developed an on-line HPLC analyzer system used for automatic control of purification columns and biosynthetic reactors.
  • The in-house built systems were utilized in multiple plant sites worldwide. Applied over 100 photometric analyzer systems to automate production processes.
  • Organized and developed the first process ana1ytics group at Lilly, which provides support for the analyzers installed by the group.
  • Designed and provided project leadership for the installation of (2) laboratory chromatography data systems. Analytical Development, Lilly Research Laboratories.
  • Responsible for development and implementation of methodologies for automation of laboratory tests utilized in various labs.
  • Assisted with interfacing instruments to the lab's central computer system.
  • Developed custom automated systems for sample preparation and polarographic analysis of cephalosporin antibiotics, sampling of dissolution testing apparatus, and screening for the presence of nitrosamines in cosmetics.

Analytical Development. Lilly Research Labs, 1972 - 1981

  • Responsible for development and implementation of methodologies for automation of laboratory tests utilized in various labs.
  • Assisted with interfacing instruments to the lab's central computer system.
  • Developed custom automated systems for sample preparation and polarographic analysis of cephalosporin antibiotics, sampling of dissolution testing apparatus, and screening for the presence of nitrosamines in cosmetics.

Honors & Publications


Credentials

  • Graduate Coursework: Biochemistry, chromatography, spectroscopy, and hazardous materials management, Indiana University-Purdue University Indianapolis and Indiana University School of Medicine.
  • Soft Skills Seminars (Eli Lilly): Results Through People, Managing Interpersonal Effectiveness, Effective Collaboration, Targeted Selection, Supervisory Skills Workshop, Interaction Management, Instructor Development Workshop-How People Learn, Performance Appraisal and Coaching, Time Management, Performance Excellence Concepts and Examples
  • Technical Seminars/Workshops: Fix-DMACS Programming (Intellution), On-Line FTIR User's Seminar (Laser Precision), Near-Infrared Analysis Seminar (Perstorp Analytical), Measurements (Eli Lilly), and Control Theory (Eli Lilly)

Academic and Professional Affiliations

  • The International Society for Measurement and Control.
  • FDA Process Analytical Technology Sub-Committee
  • PhRMA PAT Expert Working Team
  • PDA PAT Expert Working
  • USP Project Team 17 -Process Analytical Technology
  • ASTM Committee E55: Pharmaceutical Application of Process Analytical Technology
  • IFP ATma (PAT Manufacturer's Association), Chairman of the Board of Directors
  • in Biotech Discussion Panel, WCBP, Facilitator and participant PAT
  • International Forum on Process Analytical Chemistry (IFPAC).
  • Paper reviewer for the Journal of Pharmaceutical Sciences.
  • PAT Workshop Facilitator, PhRMA Bulk API Workshop
  • International Society for Measurement and Control Conference, Reviewer
  • Pharma Process Ana1ytics Roundtable - Founder
  • Advanced Separations Session
  • PharmaiBiotech International Forum on Process Analytical Chemistry
  • Journal of Process Analytical Technology
  • Pharmaceutical Review
  • Journal of Process Analytical Chemistry
  • Department of Industrial and Physical Pharmacy, Purdue University, Guest Lecturer
  • PAT Lab, Center for Pharmaceutical Process Research, Industrial Mentor,
  • University of Washington, Center for Process Analytical Chemistry, Technical Advisor

Publications and Conferences

  • Author and Co-Author of many publications, (National and International) for numerous venues and workshops.

Education

  • B.S. Chemistry, Purdue University, Indianapolis, IN
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