Experience

• 

  Aspen South African Operations

  • South Africa
  • Pharmaceutical Manufacturing
  • 300 - 400 Employee

  • Analytical Subject Matter Expert

    • Apr 2022 - Present

    Provide expert inputs and lead the resolution of problematic scientific investigations in the QC Lab.▪ Review emerging analytical technologies, assess feasibility, establish a business case and implement best practices when necessary.▪ Provide expert scientific coaching to analytical teams.▪ Develop systems and processes for conducting investigationswithin GMP requirements.▪ Evaluate analytical equipment and techniques.▪ Reduce Laboratory OOS with effective Preventative Actions.

  • SME Analytical Consultant

    • Jun 2021 - Mar 2022

    Functions & Responsibilities:• Manage Technical Transfer of products into Aspen PE facility.• Provide analytical support as an analytical SME• Co-ordinate analytical method development and validation activities• Co-ordinate stability testing activities

• 

  Amka Consulting (Pty) Ltd

  • Port Elizabeth

  • Analytical Associate

    • Jan 2021 - May 2021
    • Port Elizabeth

    Functions & Responsibilities:• Provide analytical support as an analytical SME• Setting up product offerings / services for Amka Consulting. This included the following: Analytical Method Transfer, Analytical Method Validation and Stability Studies.

• 

  Aspen South African Operations

  • South Africa
  • Pharmaceutical Manufacturing
  • 300 - 400 Employee

  • Analytical Laboratory Manager

    • Jun 2012 - May 2020

    • Manage 6 Laboratory Group Leaders who have a total of ± 90 laboratory staff reporting to them.• Analytical method development/validation, Stability and Technical Support sections report into me.• Ensure that the laboratory meets MCC, TGA, FDA, WHO requirements• Technical transfer of products into Aspen PE facility

  • Analytical Development and Validation Manager

    • Sep 2008 - May 2012

    • Manage 9 laboratory staff.• Manage analytical method development/validation• Provide analytical expertise.• Advise on new methods/techniques and instrumentation• Review new technologies that will improve laboratory efficiency•Define/design protocols that meet global regulatory requirements

  • QC Lab Support Services Manager

    • Feb 2007 - Aug 2008

    • Manage ± 30 laboratory staff.• Includes maintenance and calibration staff as well as admin staff.• Manage analytical aspects of customer complaints• Provide advise on analytical methods.• Purchasing of new equipment for lab• UPLC project – managing the conversion of HPLC methods to UPLC

  • Various Lab Positions

    • Jan 2002 - Jan 2007

    Projects Chemist• Assist with technical problems, Problem solving, provide advise on analytical methods.• Identify possible degradation products during processing• Propose new methods/techniques and instrumentation. e.g. UPLC – reduce HPLC runtime by 400%. • Define specifications required for analyses and validation• Method development/validation training.• Empower System administrator – provide software and hardware training• HPLC calibration/qualificationValidation Section Head• Oversee method development and validation• Provide input into Feasibility studies -analytical aspects.• Keep method development/validation protocols current with International requirements• Provide technical support to factory operations• Review and approve raw data generated for validation• Millennium System Administrator• Evaluate and advise management on new technology• Training and Development of staff

• 

  Plascon Paints

  • Port Elizabeth

  • Raw Material Section Head

    • Oct 2000 - Dec 2001
    • Port Elizabeth

    • Instrument/equipment calibration.• Ensuring that RM section works productively.• Analytical training.• Problem solving.• Customer complaints.

• 

  Aspen South African Operations

  • Various Lab Positions

    • Jan 1991 - Sep 2000

    Various Lab Positions:ChemistLab Maintenance Section HeadSenior Chemist