Michelle Peake SeerPharma

BScJ (Physics, Physical Chemistry, Chemistry and Biological Chemistry), Griffith University

Over 30 years of experience and expertise in:
• Sterile and Aseptic Manufacturing
• Biological Manufacturing
• GMP Consulting and Training
• QMS Design and Implementation
• Qualification and Validation
• Technical Transfer
• cGMP (FDA and PIC/S) Auditing and Gap Assessments
• GCP Auditing

Michelle has over 30 years biopharmaceutical experience specializing in Quality Assurance, Quality Control, Process Development and cGMP Production. This includes over 20 years in clinal trial and commercial manufacturing companies for sterile injectables. Michelle’s operational experience includes the design and construction of a GMP compliant biologics manufacturing facility in Penang, Malaysia, obtaining GMP accreditation for a facility in the UK and leading a successful QP EMA audit for a biologics facility in Indonesia. Her main area of experience is GMP compliance from the initial design of a facility through to process validation activities