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Dennis Roger Jenke, Ph.D.

Chief Executive Scientist, Triad Scientific Solutions

dennisjenke@triadscientificsolutions.com

 

CAREER SUMMARY

 

Over 30 years of direct technical experience in the pharmaceutical, environmental, mining, geoscience and chemical industries.  Authored over 150 publications in related areas.  Various patents related to pharmaceutical formulations (I.V. therapy).  Recognized global expert in:

 

  • Material/Solution Interactions (Extractables/Leachables, Drug Binding).

  • Support of Global Product Registrations for Pharmaceutical Products.

  • Computer Simulation of Industrial and Scientific Processes (migration modeling).

  • Problem resolution for product/process development, implementation, and lifecycle management.

  • Analytical method development/validation

  • Chromatography (LC, GC, IC, TLC).

  • Mass Spectrometry (MS)

  • Atomic Spectroscopy (ICP, AA, GFAAS, AE).

  • Instrumental Analysis (IR, NMR, UV).

  • Classical and Wet Chemical Methods; Flow Injection Analysis (FIA).

  • Metrology and Computerized System Validation.

 

 

PROFESSIONAL EXPERIENCE

 

Triad Scientific Solutions,  Hawthorn Woods, IL.                                                                        2016 to Present.

A provider of science-based solutions to plastic/product compatibility challenges associated with packaging, manufacturing equipment and delivery devices in the pharmaceutical, cosmetic, food and related industries

 

Chief Executive Scientist

 

Leveraging broad experience supporting product development, registration, and life-cycle management and an extensive network of experts and contract services providers, Dr. Jenke uses good science, practically applied, to address and overcome the challenges associated with managing interactions that occur between drug products and their manufacturing, packaging and delivery systems, insuring that such interactions (for example, extractables, leachables and drug binding) do not adversely affect the product’s key quality attributes including safety, purity, efficacy, stability, and suitability for use.

 

Baxter Healthcare Corporation,  Round Lake, IL.                                                                        1983 to 2016 (retired).

A Fortune 75 company developing, manufacturing and marketing diversified medical care products and services.

 

Baxter Distinguished Scientist, Baxter Analytical Center of Excellence (ACoE)

 

Dr. Jenke was a Distinguished Scientist at Baxter Healthcare Corporation where for more than three decades he led the corporate function charged with establishing material/product compatibility, specifically with respect to establishing the suitability for use of packaging systems, manufacturing systems and administration devices for pharmaceutical products (for example, extractables/leachables and product ingredient binding).  In this role, Dr. Jenke prepared, reviewed and defended product registration submissions.  Dr. Jenke created and shaped domestic and global policies in the areas of product characterization, thereby developing, optimizing, and implementing Corporate-wide strategies for material/solution compatibility assessment.  As a Distinguished Scientist and a highly published, globally recognized expert in the field of chemical evaluation of material/solution interactions, Dr. Jenke has driven international efforts to generate standards for material/solution compatibility assessments.

 

AWARDS AND AFFILIATIONS

 

Dr. Jenke’s memberships in industry-wide organizations responsible for the development of global standards and best practices addressing material/solution compatibility include:

 

  • Chair, Chemistry Working Group, Product Quality Research Institute (PQRI) Extractables and Leachables Taskforce for Parenteral and Ophthalmic Drug Products (PODP).

  • Member, United States Pharmacopeia (USP) Packaging and Distribution Expert Committee; including:

    • Chair, Expert Panel for USP Chapters on Polymers Used in Pharmaceutical Packaging <661>, <661.1>. <661.2>, >1661>

    • Chair, Expert Panel for USP Chapters on Polymers used in Manufacturing Components and Systems <665>, <1665>

    • Member, Expert Panel for USP Chapters on Elastomeric Closures, <381>, <382>, <1381>, <1382>

  • Adjunct Member, United States Pharmacopeia (USP) Combined Pharmaceutical Waters Expert Panel.

  • Association for the Advancement of Medical Instrumentation (AAMI), Biological Evaluation Committee:

    • BE/WG02, Degradation Aspects Related to Biological Testing, Committee Alternate

    • BE/WG12, Allowable Limits for Leachable Substances, Committee Member

    • BE/WG12, Sample Preparation and Reference Standards, Committee Member

    • BE/WG14, Material Characterization, Committee Member

 

 Dr. Jenke was a Past President, Chicago Chromatography Discussion Group and the past Chair, Board of Directors, and current Scientific Advisor to the Extractables & Leachables Safety Information Exchange (ELSIE).

 

Dr. Jenke is an expert Reviewer for numerous technical journals including Analytical Chemistry, PDA Journal of Pharmaceutical Science and Technology, Journal of Chromatographic Science, Journal of Chromatography, Journal of Applied Polymer Science, Pharmaceutical Research, International Journal of Pharmaceutics.  He is an Associate Editor for the Journal of Chromatographic Science and an Editorial Board member for Pharmaceutical Outsourcing. 

 

External recognition received by Dr. Jenke includes:

 

  • Received the 2005 Frederick D. Simon Award for Best Technical Manuscript published in the PDA Journal of Pharmaceutical Science and Technology (2005). 

  • Received the USP Award for an Innovative Response to a Public Health Challenge for “outstanding dedication and service in evolving the breadth and scope of standards for pharmaceutical packaging”. 

  • Received Leadership (2014) and Chair (2015) Awards from the Extractables and Leachables Safety Information Exchange (ELSIE), for outstanding service and contributions to that organization.

  • Recognized as a member of the Pharmaceutical Power List by Medicine Maker Magazine (2015).

  • Received “Expert Certification” from the Chinese National Pharmaceutical Packaging Association (CNPPA, 2016) as an invited Technical Consultant.

 

 

EDUCATION

 

Masters in Business Administration (with distinction); Keller Graduate School of Management, 1992; Course work emphasis in strategic, personnel and general business management.

 

Ph.D. in Analytical Chemistry; Montana State University, 1983; Theoretical and practical studies of ion chromatography, modeling of separation processes and optimization of the methodology in practical applications.

 

M.S in Geochemistry; Montana College of Mineral Science and Technology, 1978; Chemical characterization and modeling of an industrial wastewater treatment process.

 

B.A. in Chemistry, Mathematics, Physics; Illinois College, 1975; Second “triple major” in College’s 160-year history; varsity letters in tennis and football; member Phi Alpha Literary Society.