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TONY JONES

Contact: fjones170901@comcast.net

SUMMARY

Scientific Manager and Leader with record of success in British, American and French organizations.

CAREER HISTORY

2000 to date:  Taylor Technology, Inc., Princeton, New Jersey, USA.

Director of Quality Assurance

  • Responsible for the Quality Assurance Unit (QAU) of a Contract Research Laboratory providing bioanalytical services to the pharmaceutical industry.

  • Leads and manages a team of six Auditors to provide effective and efficient Quality Assurance.

  • Oversees all company operations to assure compliance with current regulations and regulatory expectations.  Initiates and participates in process improvement activities.

  • Provides Quality Assurance training, through design and delivery of structured modules.

  •  Serves as primary company liaison with regulatory agencies, hosted a 6-day FDA inspection in 2002 classified as NAI (no FDA-483).

  • Responsible for collaborations between company personnel and sponsor QAU’s, hosts regular audits and inspections by major pharmaceutical companies.

  •   Active involvement in the QA profession: Director of the Mid-Atlantic Regional Society of Quality Assurance (MARSQA); member of MARSQA Computer Validation Committee; Program Leader, MARSQA Analytical Chemistry course.

1996 - 2000:  Laboratoires Fournier SA, Dijon, France.

Chargé d'Etudes en Pharmacocinétique Clinique

Key managerial position in group performing all phase I clinical studies.  Two main roles:

1.    Clinical

  • Protocol design; selection, contract negotiation and audit of CRO's; co-ordination of studies with supervision of a Clinical Research Associate.

  • Pharmacokinetic (PK) data analysis and reporting.

  • Project Team Member with responsibility for clinical PK aspects of Hormone Replacement Therapy (HRT) new product development. Managed two PK development programmes, including participation in NDA preparation, commended by the Project Leader for consistently meeting all timings and quality standards.

2.    Analytical

  • Manager of a GLP-compliant bioanalytical laboratory and two technicians.

  • Principal Investigator for all bioanalytical studies.

  • Responsible for the provision of external bioanalytical support for all phase I-III clinical studies, monitoring of bioanalytical CRO’s and review of bioanalytical reports.

Therapeutic areas:  Immunology, HRT, Cardiovascular.

1988 - 1996:  SmithKline Beecham Consumer Healthcare Ltd., Weybridge, Surrey, England.

Research Manager, Cross-Category Technologies Group  (1993 - 1996).

  • Managed research projects with UK academia and other UK/US SmithKline Beecham sites to assess novel technologies in drug delivery and evaluation, including in vitro/in vivo correlation.  Application to topical, oral modified‑release (Panadol® and Contac®) and inhalation/transdermal products.  Project Leader for Topical Biopharmaceutics Project Team.

  • Liaised closely with Regulatory and Medical groups to provide biopharmaceutics input for European Product Licence Applications.

  • Prepared and managed budget of up to £200,000.

Section Manager, Biopharmaceutics Group  (1991 - 1993).

  • Manager of group performing bioanalytical work and PK analysis.  Application of PK and PK/PD to dosage form design and assessment.  Designed and introduced a GLP‑compliant Quality Improvement Programme.  Placed contracts for bioanalytical and clinical work.

  • Senior Scientist, Applied Research Group  (1990 - 1991).

  • Performed bioanalytical work and PK analysis.  Prepared protocols and reports in support of clinical studies.

Scientist, Applied Research Group  (1988 - 1990).

  • Developed, validated and applied bioanalytical methods.  Co-ordinated clinical studies in healthy volunteers.

Therapeutic areas:  OTC medicines, Analgesics, Gastrointestinal, Upper Respiratory Tract, Dermatology.

1985 - 1988:  NHS Laboratories, West Midlands and Surrey, England.

Biochemist

Practical and interpretative clinical chemistry.  Routine analysis and method development of assays for drugs and steroid hormones using RIA/HPLC/TLC/GC/GC-MS.  Secondments to

Therapeutic areas:  General medicine, Endocrinology, Toxicology.

1984 - 1985:  Goodyear Tyres, Wolverhampton, England.

Compounder

Technical supervision and monitoring of processing, participation in productivity and quality improvement initiatives.

ACADEMIC AND PROFESSIONAL QUALIFICATIONS

2003 Director, MARSQA.
2002 Member MARSQA Computer Validation Committee.
2000 to date   Program Leader MARSQA ‘Analytical Chemistry for Quality Assurance’, Pennsylvania, USA.
2000 Affiliate Member, Society of Quality Assurance.
1995 to 2000  Honorary Lecturer (pharmacokinetics) at the University of Kent, Canterbury, England.
1994 Associate Member, AIMgt, Institute of Management.
1991 Chartered Chemist, CChem MRSC, Royal Society of Chemistry.
1983 B.Sc. (Hons) Chemistry with Biochemistry, Class 2.i, Leicester University, England.

LANGUAGES

English mother tongue.

Fluent spoken French, good standard of written French.

COMPUTER SKILLS

Fully conversant with Microsoft software (Word, Excel, Project) specialist pharmacokinetic packages (WinNonlin, Kinetica, Topfit); groupware (Lotus Notes); project planning (PSN6, On Target), relational databases (4D) and the Internet.

Detailed knowledge of verification and validation activities for computerized applications.

PUBLICATIONS

  • Principles in Quality Assurance. Part 2: Don’t Hide Behind The Regulations.  Jones AB.  Quality Assurance Journal, 2003;7(1):In Press.

  • Principles in Quality Assurance. Part 1: Sink or Swim. Jones  AB. Quality Assurance Journal, 2002;6(4):219-225. 

  • Comparison of the pharmacokinetics of 17b-estradiol after a single 4-day application of Oesclim 50, Oesclim 100 and Vivelle 0.05 (Menorest 50) transderrmal delivery systems. Guichard JP, Sauron R and Jones AB. J Clin Pharmacol 1999;39:811-816.

  • Determination of in vitro dextromethorphan permeability: comparison with in vivo absorption measured by pharmacoscintigraphy. Ball C, Hildago IJ, Jones AB et al. Minutes, European Symposium, In vitro and ex vivo test systems to rationalize drug design and delivery, Editions de Santé, 1994:301-304.

  • GLP as part of a quality improvement programme. Jones AB. Laboratory of the Government Chemist, VAM Bulletin, 1992;8:8-10.

OTHER INFORMATION

Comprehensive training including courses in pharmacokinetics (M. Rowland Basic and Advanced), management (business skills, interviewing, objective setting, time management, coaching) and Quality/GLP.

Other interests include playing guitar, karate.

Date of birth 21 December 1961, British nationality.

REFEREES

Available on request.

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