Experience

Immutep Limited

• Australia
• Biotechnology Research
• 1 - 100 Employee

• Manufacturing Manager

  • Apr 2022 - Present

  Supervision of process scale up and GMP production at CDMO (USP, DSP, DP) Review and approval of development, tech transfer protocols/ reports, analytical methods and IMPD (CMC part) updates SME for process characterization and validation planning including budget & timelines Main author for CQA risk assessment Supervision of process scale up and GMP production at CDMO (USP, DSP, DP) Review and approval of development, tech transfer protocols/ reports, analytical methods and IMPD (CMC part) updates SME for process characterization and validation planning including budget & timelines Main author for CQA risk assessment



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Engineer Process Validation (PPQ Readiness & Launch H773)

  • Nov 2020 - Mar 2022

  Project: Upgrade of an R&D clinical supply plant to enable commercial production of recombinant antibodiesResponsible for timely delivery of concepts and documents to support PPQ and validationSupporting execution of validation activities, writing reports. Lead team of up to 5 people. Represent Validation in audits.

• Consultant Technical Compliance Engineer

  • May 2019 - Nov 2020

  Project: Upgrade of an R&D clinical supply plant to enable commercial production of recombinant antibodiesResponsible for conducting gap analyses, remediation planning and executionPreparation of concepts and documents to support qualification and validation



Bayer

• Chemical Manufacturing
• 700 & Above Employee

• Process Specialist Validation

  • Aug 2014 - May 2019

  • Lead for cleaning validation within the project • Author of VMPs and validation plans, SOPs, changes, deviations, CAPAs and risk assessments • Responsible for planning and execution of cleaning development studies and cleaning validation • Management of contractors supporting the validation activities (7 people) • Cooperation with global and local tech transfer, validation, QA, QC. production and C&Q functions • Lead for cleaning validation within the project • Author of VMPs and validation plans, SOPs, changes, deviations, CAPAs and risk assessments • Responsible for planning and execution of cleaning development studies and cleaning validation • Management of contractors supporting the validation activities (7 people) • Cooperation with global and local tech transfer, validation, QA, QC. production and C&Q functions



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Process Development Engineer

  • Jun 2004 - Jul 2014

  • Responsible for planning, execution and interpretation of fermentation experiments (scale 4mL to 250L with CHO and E. coli cell lines) using statistical methods and DoE • Participated in process transfer actvities within the site (from early research and to GMP production) and globally with US sites • Calculated process parameters for up scale and down scale of fermentation processes • Participated in the development of a chemical defined media plattform for CHO cell lines • Executed a small scale study in support of a process change in commercial production • Supervised interns and bachelor/ diploma thesis students • Responsible for sourcing, commisioning and qualification of bioreactors and other equipment • Responsible for a project implementing single use equipment in the pilot plant • Author and trainer for methods, master batch records and SOPs Show less