Manager and Leader with record of success in British, American and French organizations.
to date: Taylor Technology, Inc.,
Princeton, New Jersey, USA.
Director of Quality Assurance
for the Quality Assurance Unit (QAU) of a Contract Research Laboratory
providing bioanalytical services to the pharmaceutical industry.
and manages a team of six Auditors to provide effective and efficient
all company operations to assure compliance with current regulations and
regulatory expectations. Initiates
and participates in process improvement activities.
Quality Assurance training, through design and delivery of structured
as primary company liaison with regulatory agencies, hosted a 6-day FDA
inspection in 2002 classified as NAI (no FDA-483).
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
- 2000: Laboratoires Fournier SA,
Chargé d'Etudes en Pharmacocinétique Clinique
Key managerial position in group
performing all phase I clinical studies. Two
design; selection, contract negotiation and audit of CRO's; co-ordination of
studies with supervision of a Clinical Research Associate.
(PK) data analysis and reporting.
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.
of a GLP-compliant bioanalytical laboratory and two technicians.
Investigator for all bioanalytical studies.
for the provision of external bioanalytical support for all phase I-III
clinical studies, monitoring of bioanalytical CRO’s and review of
areas: Immunology, HRT,
- 1996: SmithKline Beecham
Consumer Healthcare Ltd., Weybridge, Surrey, England.
Research Manager, Cross-Category Technologies Group
(1993 - 1996).
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.
closely with Regulatory and Medical groups to provide biopharmaceutics input
for European Product Licence Applications.
and managed budget of up to £200,000.
Manager, Biopharmaceutics Group (1991
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.
Scientist, Applied Research Group (1990
bioanalytical work and PK analysis. Prepared
protocols and reports in support of clinical studies.
Applied Research Group (1988
areas: OTC medicines, Analgesics,
Gastrointestinal, Upper Respiratory Tract, Dermatology.
- 1988: NHS Laboratories, West
Midlands and Surrey, England.
interpretative clinical chemistry. Routine
analysis and method development of assays for drugs and steroid hormones using
areas: General medicine,
- 1985: Goodyear Tyres,
supervision and monitoring of processing, participation in productivity and
quality improvement initiatives.
ACADEMIC AND PROFESSIONAL QUALIFICATIONS
MARSQA Computer Validation Committee.
Leader MARSQA ‘Analytical Chemistry for Quality Assurance’, Pennsylvania, USA.
Member, Society of Quality Assurance.
Lecturer (pharmacokinetics) at the University
of Kent, Canterbury, England.
Member, AIMgt, Institute of Management.
Chemist, CChem MRSC, Royal Society of Chemistry.
||B.Sc. (Hons) Chemistry with Biochemistry, Class 2.i, Leicester University,
spoken French, good standard of written French.
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.
knowledge of verification and validation activities for computerized
in Quality Assurance. Part 2: Don’t Hide Behind The Regulations. Jones AB.
Assurance Journal, 2003;7(1):In Press.
in Quality Assurance. Part 1: Sink or Swim. Jones AB.
Quality Assurance Journal, 2002;6(4):219-225.
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
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.
as part of a quality improvement programme. Jones AB. Laboratory of the
Government Chemist, VAM Bulletin, 1992;8:8-10.
training including courses in pharmacokinetics (M. Rowland Basic and Advanced),
management (business skills, interviewing, objective setting, time management,
coaching) and Quality/GLP.
interests include playing guitar, karate.
of birth 21 December 1961, British nationality.