Summary
Overview
Work History
Education
Skills
Personal Information
References
Timeline
Generic

Dale Withington

Summary

With over 24 years of experience in a heavily scrutinized pharmacuetical laboratory. I have gained the skills follow laboratory equipment through its life cycle. My skills in Analytical services, have involved working as a team to devise Anaytical methods and validations for the testing of new produces (both API and Non API) to GMP standards, following PIC/s (TGA) USP and EP regulations. I was part of the team that worked to get FDA and TGA approval for Tasmanian Alkaloids to sell Buprenorphine,

  • Design qualification (determining it's suitability)
  • Organise it's purchase
  • Installation Qualification (organised it's set up in the laboratory)
  • Operational Qualification ( Prove it will work as the manufacturer says it will)
  • Develop operational methods (both on a mechanical level and software level)
  • Performance Qualification (test the stringency of the method)
  • Write operational procedures, and train the users
  • Devise and execute calibration and preventative maintenance programs using CMMS
  • External vendor contact in the supply of goods and services ( Contracts, repairs and qualifications).
  • Repairing any instruments ( first port of call).
  • Organising and maintaining instrument parts.
  • Coordinating with managers/analysts/external service engineers any maintenance/calibrations that I cant do ( such as qualifications and PM that require certain certifications).
  • Retiring any instrument, no longer used and all the associated paperwork required to do so.

Overview

27
27
years of professional experience

Work History

Technical Services Senior Scientist

Tasmanian Alkaloids / Extractas Bioscience
Westbury, TAS
11.1999 - Current

Worked in Analytical Services ( Method Development/Validation and non-routine testing). Worked in Technical Services (Laboratory purchased, repair, calibration, qualification and use).

Customer Service Representative

Medicare
Launceston, TAS
01.1997 - 11.1999
Interacted with customers

Education

Bachelor of Science - Chemistry

University of Tasmania, Inveresk Campus
1999

Skills

  • Knowledge in UPLC, HPLC, IR, FTIR, NIR, Polarimeters, KF, headspace and liquid injection GC and other laboratory equipment
  • Experience with Maximo (CMMS), in the creation, reviewing and
  • laboratory testing such as Residue on ignition, LOD
  • GLP, GAMP environment
  • Knowledge in USP, EP, PIC/s (TGA)
  • Extensive experience with a number of LIMS systems ( MasterControl, Materials database and EMS)
  • First aid level 2 certified
  • Lab maintenance expert
  • Qualification of new and existing laboratory equipment (eg FTIR, Analytical Balances, KF, UV Spectrophotometer)
  • Administrator of Computer programs such as Empower 2 and 3, OMNIC, OPUS, Chemstation, Insight Pro
  • Procedure writing, reviewing and lead training
  • Report writing and reviewing
  • Deviation and CAPA writing
  • Technical Support and its management

Personal Information

  • Place of Birth: Launceston, Tasmania, Australia
  • Date of Birth: 9th of November 1974
  • Present Launceston, Tasmainia
  • Sex: Male
  • Status: Married with 1 child (age 12)
  • Hobbies: Health active lifestyle choices (frequent gym user, healthy). Bushwalking, running. Assisting my partner with her retail business (The Spotted Quoll Studio). Spending time with my son.

References

  • Rodney Bussey, Maintenance & Utilities Manager
  • Extractas Bioscience
  • Mobile: 0439223417
  • Email: rodney.bussey@extractas.com.au
  • Parnee McKercher, Regulatory Affairs, Validation & Analytical Supervisor
  • Extractas Bioscience
  • Mobile: 0407320817
  • Email: parnee.mckercher@extractas.com.au
  • Peter Crawford, Certified Accountant (joint owner)
  • Cradix Business Managers& Accountants
  • Office: 63266255
  • Email: peter@cradix.com.au
  • Tamika Bannister, Director
  • The Spotted Quoll Studio
  • Office: 0418311398
  • Email: Thespottedquoll@bigpond.com
  • Matthew Gray, IT Specialist
  • Launceston City Council
  • Office: 0407139184
  • Email: Matt.Gray@launceston.tas.gov.au

Timeline

Technical Services Senior Scientist

Tasmanian Alkaloids / Extractas Bioscience
11.1999 - Current

Customer Service Representative

Medicare
01.1997 - 11.1999

Bachelor of Science - Chemistry

University of Tasmania, Inveresk Campus
Dale Withington