TODD R. DAVIAU
Pharmaceutical Executive
Pinellas Park,FL
Summary
Accomplished employee-oriented, scientific leader with more than 30 years of pharmaceutical experience. From discovery through research & dosage form development, analytical (method development, validation, etc.) dosage form manufacturing, quality control and management experience in top-tier multinational pharmaceutical organizations. A global, strategic thinker, with demonstrated ability to deliver pre-clinical and clinical candidates, within stringent timelines.
Acknowledged as a creative leader focused on advancing projects with experience in multiple therapeutic areas. Expert in optimizing the drug discovery process through optimal resource allocation, process improvements and using scientific acumen to resolve complex project related issues. Recognized ability to lead, recruit, energize, mentor, reward and retain talent.
Overview
55
55
years of professional experience
4
4
years of post-secondary education
Work History
CIPAN, Chelsea Pharmaceuticals
Lisbon, New York, NY
03.1989
- Developed method to test minocycline epi-minocycline, and other degradation products for data submission and sale to pharmaceutical companies in the US.
Founder, Director of Analytical & Preformulation
CoreRx, Inc
Tampa, FL
01.2006 - Current
- Laboratory
- Esponsible for analytical laboratory
- Also responsible for SOP's and validation protocols for laboratory equipment and computer software.
Director
MDS Pharma Services
Tampa, FL
06.2004 - 07.2006
- Analytical & Preformulation Laboratory
- Responsible for group of 22 involved in analytical methods development and validation as well as sample analysis of bulk drug, raw materials and finished product dosage forms utilizing HPLC
- Also responsible for SOP's and validation protocols for laboratory equipment and Galaxie Chromatography Data System.
- Focused teams on developing innovative and cutting-edge approaches with effective resource allocation and strategic planning.
- Created annual budget and developed comprehensive plan to accomplish company objectives while staying within budget.
Field Technical Support Specialist
Shimadzu Scientific Instruments, Inc
Columbia, MD
01.1999 - 01.2004
- Responsible for support of sales for the entire instrument line (Software, UV-Vis, FTIR, HPLC, GC, GC-MS, LC-MS, TOC, and Thermal Analysis) including equipment/software demonstrations
- Also responsible for customer training, application support and method development support of entire product line.
Smith+Nephew
Largo, FL
04.1999 - 07.1999
- Developed and Validated HPLC Methods for the assay of preservative materials in the Company’s topical wound care products
R.P Scherer
Saint Petersburg, FL
02.1999 - 05.1999
- Assisted in the assay of the entire line of the Company’s Soft-gel products
- Also developed and validated methods for the assay of vitamin products.
Director
SunPharm Corporation
Jacksonville, FL
01.1997 - 01.1999
- Analytical Chemistry
- Esponsible for analytical methods development and validation as well as sample analysis of bulk drug, raw materials and finished product dosage forms utilizing HPLC
- Also responsible for SOP's and validation protocols for laboratory equipment and computer software
- Responsibilities also for documentation (CMC Sections) in support of Regulatory filings (IND’s, NDA’s).
Scientist
Guilford Pharmaceuticals, Inc, Scios Nova, Inc
Baltimore, MD
01.1995 - 01.1997
- Analytical Research and Development
- Esponsible for analytical methods development and validation as well as sample analysis of bulk drug, raw materials and finished product dosage forms utilizing GC (GC/MS), GPC and HPLC
- Also responsible for SOP's and validation protocols for laboratory equipment and computer software
- Responsibilities also for documents in support of IND and NDA submissions
- Supervisory responsibility for 6 BS and 2 AA level chemists.
Manager
Red Sea Fish pHarm, Inc
Owings Mills, MD
01.1994 - 01.1996
- US Sales Responsible for establishing and maintaining wholesale accounts to firms specializing in specialty chemicals and electronic devices for public and private aquariums
- Also responsible for training wholesale sales representative and holding informal discussions on testing, chemicals and their uses at top-performing retail accounts.
Oceanix
Linthicum, MD
03.1993 - 09.1995
- Marine microbial fermentation and extractions providing extracts for company's screening program.
Martek
Columbia, MD
10.1992 - 09.1995
- Provided company with sponge tissues in addition to field conditions and data for dinoflagellates collected in Bermuda for culture work.
Harris, FRC
Columbia, MD
10.1994 - 05.1995
- Wrote and presented training courses to various pharmaceutical firm in the areas of GLP's and cGMP's compliance.
Staff Research Associate
SCIOS-NOVA, Inc
Baltimore, MD
01.1989 - 01.1994
- Analytical & Physical Pharmacy
- Esponsible for analytical methods development and validation as well as sample analysis of bulk drug, raw materials and finished product dosage forms utilizing GC, CE & HPLC
- Hromatography System Manager, Responsible for the day to day operations, training and validation of the DEC Microvax II as well as analytical instrumentation
- Chosen as Beta test site System Manager by Beckman Instruments for Revs
- 2.0, 2.1, and 2.2 of their PeakProTM Chromatography Software
- Supervised 2 BS level chemists.
Maryland Science Center
Baltimore, MD
01.1990 - 09.1992
- Maintained Chesapeake Bay live exhibit including large 2800 gallon aquarium and 17 smaller aquariums with species indigenous to Chesapeake Bay
Reserves Petty Officer
U.S. Coast Guard
01.1982 - 01.1992
Project Leader
PharmaKinetics Laboratories, Inc
Baltimore, MD
01.1988 - 01.1989
- Drug Stability and Dissolution
- Responsible for analytical methods development and testing in compliance with client's specifications and compendial methods
- Also responsible for stability testing according to standard operating procedures established by various pharmaceutical manufacturers in compliance with GMP's
- Supervised 1 BS and 2 AA level chemists., Research and Development
- Developed and validated methods for the determination of a variety of drugs and their metabolites in biological matrices.
Project Leader
Quad Pharmaceuticals
Indianapolis, IN
01.1987 - 01.1988
- Research and Development
- Eveloped specifications for raw materials, dosage forms and packaging materials
- Responsible for establishing SOP's for testing and release of drug substances, excipients and preservatives
- Developed and validated analytical methods to support new product development and regulatory submissions for a wide variety of generic parenterals
- Also responsible for analytical and stability package for ANDA's
- ACCOMPLISHMENTS
- Stablished Computer System Validation programs (including SOP’s, protocols, and final reports)
- Instituted and designed stability protocols for OTC and ethical pharmaceuticals including: protocols, SOPs, etc
- Set up and maintained Corporate-wide calibration programs
- Instituted Corporate-wide Documentation systems
- Maintained environmental monitoring systems and investigations
- Development GMP compliance programs and training
- Cut previous budget costs by over $50,000 while taking on more activities
- Designed and oversaw construction of two separate analytical testing facilities
- Specified/designed, purchased, inspected, and validated equipment at significant savings for each step in time and money
- Developed and validated methods for several pharmaceutical raw materials, finished products and drug/metabolite analyses
- Modified method to remove costly and time-consuming solid-phase extraction step in the analysis of Phase II Pharmaceutical Product
- Sent to pharmaceutical manufacturer and raw material suppliers in Portugal and New York to troubleshoot compendial method for minocycline/epi-minocycline raw materials
- Named to Committee for Baltimore City Community College to design Associates level degree in biotechnology.
Education
Bachelor of Science - Chemistry and Marine Biology
01.1985 - 01.1986
GPA: 3.60/4.00, - Senior Chemistry Award for Academic Achievement
- Who's Who in American Universities and Colleges (1984-85 and
MBA - Management
03.2012 - 12.2014
Skills
(parenterals; liquids and lyophilized, solids, polymers, and gels) Also an experienced team manager having led a team of over 10 analysts Proficient in the use of computers Experience with several operating systems for the acquisition and manipulation of chromatographic data Also experienced in the use of all types of analytical instrumentation (LC, GC, LC-MS, GC-MS, TOC, and spectro), as well as extraction and derivatization procedures
Corporate leadership
Policy development and optimization
Mergers & acquisitions
Business alliances
Affiliations
American Chemical Society (ACS)
American Association of Pharmaceutical Sciences (AAPS)
American Organization of Analytical Chemists (AOAC)
American Society of Pharmacognosy (ASP), SCUBA Diving (Openwater, Advanced, Night, Wreck, - NAUI and PADI), spearfishing, U/W photography
Marine Reef Aquariums
Home brewing/Winemaking
Computers (web site design, graphics, etc.)
Timeline
Florida Institute of Technology-Melbourne - MBA, Management
03.2012 - 12.2014
Founder, Director of Analytical & Preformulation - CoreRx, Inc
01.2006 - Current
Director - MDS Pharma Services
06.2004 - 07.2006
- Smith+Nephew
04.1999 - 07.1999
- R.P Scherer
02.1999 - 05.1999
Field Technical Support Specialist - Shimadzu Scientific Instruments, Inc
01.1999 - 01.2004
Director - SunPharm Corporation
01.1997 - 01.1999
Scientist - Guilford Pharmaceuticals, Inc, Scios Nova, Inc
01.1995 - 01.1997
- Harris, FRC
10.1994 - 05.1995
Manager - Red Sea Fish pHarm, Inc
01.1994 - 01.1996
- Oceanix
03.1993 - 09.1995
- Martek
10.1992 - 09.1995
- Maryland Science Center
01.1990 - 09.1992
- CIPAN, Chelsea Pharmaceuticals
03.1989
Staff Research Associate - SCIOS-NOVA, Inc
01.1989 - 01.1994
Project Leader - PharmaKinetics Laboratories, Inc
01.1988 - 01.1989
Project Leader - Quad Pharmaceuticals
01.1987 - 01.1988
Roger Williams University - Bachelor of Science, Chemistry and Marine Biology
01.1985 - 01.1986
Reserves Petty Officer - U.S. Coast Guard
01.1982 - 01.1992