MERLIN K. L. BICKING, Ph.D.

Woodbury, MN 55125
Phone: (651) 731-3670
Fax: (651) 730-0965
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EDUCATION:

Bachelor of Science - Chemistry
University of Wisconsin - River Falls, WI
Doctor of Philosophy - Organic-Analytical Chemistry
Iowa State University - Ames, IA

TECHNICAL INTERESTS AND EXPERIENCE:

Technical Training and Problem-Solving
Analytical Separations
Experimental Design/Method Development
Medical Device Development

QUALIFICATION SUMMARY:

General Experience

  • More than 20 years post-graduate experience in academia, contract research, contract
  • laboratory, and independent consulting.
  • A problem-solving, organic-analytical chemist.
  • Design, manufacture, and testing of implantable medical devices.
  • Currently an independent contractor for the biomedical device, pharmaceutical, food, scientific instrument, manufacturing, environmental testing, and water purification device industries.
  • Extensive technical writing experience in preparation and review of technical summaries, literature reviews, risk assessment summaries, project reports, manufacturing procedures, and SOPs.
  • Listed in Who's Who in America.

Analytical Chemistry Experience

  • Knowledgeable in all aspects of analytical separations, method development, and problem-solving, using techniques such as chemical derivatization, HPLC, GC, GC/MS, SFE, SFC, FTIR, NMR, and absorbance spectrophotometry.
  • The application of experimental design strategies for chemical problem-solving and data analysis.
  • Application experience includes environmental analysis, chemical characterization, additive analysis, product deformulation, stability testing, and product characterization.
  • Developed the Practichem™ Series of Training Seminars, which provides practical technical training for laboratory staff.
  • Certified Instructor and Content Provider for Agilent Technologies software and HPLC instruments.
  • Author of two U.S. EPA analytical methods.

Medical Device Experience

  • Knowledge of Design Control, GMP, and CE Mark issues for implantable devices.
  • Preparation and review of regulatory documents (IDE, Risk Assessment, FMECA, Technical Dossiers).
  • Manufacturing process troubleshooting and optimization.
  • Member of the scientific advisory board for a medical device manufacturer.

PROFESSIONAL EXPERIENCE:

Analytical Chemistry Consulting and Training Associates, Inc. (ACCTA, Inc.), Woodbury, MN
1993 to Present. CONSULTANT and PRESIDENT
Provides independent contractor services in laboratory problem-solving, in-laboratory services, document preparation, and new technology evaluations for the biomedical device, pharmaceutical, food, scientific instrument, manufacturing, environmental, and water purification device industries. Develops and presents laboratory staff training courses on a wide variety of chemistry-related topics.

Uroplasty, Inc., Minneapolis, MN
1997 to 2001. TECHNICAL DIRECTOR
Provided technical support to all aspects of design, testing, and manufacturing of implantable medical devices. Reviewed and/or prepared technical summaries, test plans and reports, regulatory submissions, and manufacturing procedures. Evaluated new technologies for manufacturing improvements and product testing. Coordinated clinical complaints.

TCT (Twin City Testing) Corporation, St. Paul, MN
1988 to 1993. SUPERVISER, MANAGER, AND TECHNICAL DIRECTOR, Chemistry Departments
Supervisor responsibilities included management of a group of professional staff devoted to developing new methodologies or improving existing procedures. Manager responsibilities included management of a group of 15 professional and technical staff members in the following non-routine technical areas: dioxin programs, technology development (FTIR), product chemistry, agrichemical programs, and method development. As Technical Director, provided technical oversight for non-routine chemistry groups involved with routine environmental analysis, high resolution mass spectrometry, industrial chemistry, and GLP programs. Provided internal consulting and problem-solving expertise, new technology evaluation, staff training, and specialty method development.

Battelle Columbus Division, Columbus, OH.
1985 to 1988. PRINCIPAL RESEARCH SCIENTIST AND GROUP LEADER
Duties included management of nine professional and technical staff as well as operation of theHPLC laboratory. Other activities included project management, preparation of proposals and reports, and review of proposals and reports prepared by group staff members.

State University of New York-Buffalo, Buffalo, NY.
1982 to 1985. ASSISTANT PROFESSOR OF CHEMISTRY
Duties included preparing grant proposals, directing graduate and undergraduate research, teaching graduate and undergraduate courses and various committee assignments. A research program in analytical separations was developed.

PUBLICATIONS:
More than twenty (20) publications in peer-reviewed journals covering topics in high performance liquid chromatography theory, biological and environmental method development, experimental design, and supercritical fluid extraction.

PRESENTATIONS:
More than 35 presentations and invited lectures at local, national, and international meetings.

PROFESSIONAL MEMBERSHIPS:
American Chemical Society
Minnesota Chromatography Forum
Council Member and Subject Matter Expert for the GLG Group
Member of ORC Expert Advisory Services