Lisa is an active member of the PDA Regulatory Affairs and Quality Advisory Board (RAQAB) and the PDA Australia Chapter. Lisa's experience comes from a background in Forensic & Analytical Chemistry, accompanied by a Masters in Forensic Science. After beginning her career as an analytical chemist in the petrochemical industry, Lisa moved into roles within the Pharmaceutical Industry where she gained hands on experience in a wide breadth of disciplines such as QC, Stability and Clinical Trials, Supply Chain Logistics, R&D, Aseptic Fill and Finish, QA, Release for supply and auditing. The majority of her time in the industry has been in roles working within the CSL group which manufactures biological products such as vaccines, antivenoms and blood products.
Micheal Schafferius currently holds the position of Application Specialist for Separation Technologies and quality at Sartorius Australia, working for Sartorius for the past 10 years. Micheal has worked in the pharmaceutical and biopharmaceutical industries for more than 20 years. His experience includes roles focused on Filtration, Single Use Technologies, Quality Assurance, Validation and Sterile Manufacturing with local and international companies. Micheal is the current PDA Australia chapter President.
Bruce provides inspection readiness and compliance guidance to GSK Vaccines manufacturing network, focusing on AsiaPac. He is responsible for performing pre- Prior Approval Inspection (PAI) Assessments, and now has a specific remit on (i) preparing sites for first inspection, and on (ii) sharing knowledge on regulatory updates and trends into the organization.
Bruce has more than 30 years in the Pharma and Vaccines businesses, including a variety of roles in Validation and Compliance in both Drug Substance and Drug Product Manufacturing in UK, France and Singapore.
Bruce has been a PDA Singapore Chapter member since 2014, and was Chapter President from 2020-2022. Since July 2022 he has been a member of PDA's Science Advisory Board (SAB).
Dinesh. as a Director and Regional Lead of External Affairs in Amgen, is currently responsible for shaping external regulatory and GXP landscape in collaboration with industry peers and regulators in Japan Asia Pacific. Additionally, Dinesh holds the position of Adjunct Associate Professor at the Faculty of Health and Medical Sciences, Taylor's University, Malaysia.
He is an accomplished pharmaceutical professional with distinguished career of over 35 years of combined experience in regulatory agency, biopharmaceutical & diagnostic industries, and academia.
Prior to Amgen, Dinesh held the role of Director of Therapeutic Products Branch at the Singapore Health Sciences Authority (HSA). During his tenure in HSA, Dinesh held many different roles including Senior GMP Inspector. He has also played several key roles in multiagency consortiums and World Health Organization initiatives working towards capability building, shaping regulatory landscape, regulatory harmonisation, and mutual reliance.
Dinesh received his Ph.D. in Cell and Molecular Biology from the National University of Singapore. He is currently on the PDA Regulatory Affairs and Quality Advisory Board (RAQAB). He is a recipient of 2020 PDA Distinguished Service Award.
Mylinh is currently the Senior Lab Manager within the CSIRO's National Vaccine and Therapeutics Laboratory with over 20 years of experience working in both the academic research environment and the Biotech industry (Murex Biotech, Abbott Laboratory). Mylinh gained her Ph.D at the University of Melbourne (Department of Pharmacology), she is also an Alexander Von Humboldt Fellow, and a Research Fellow at the William Harvey Research Institution (University of London, UK), and an honorary senior lecturer in immunopharmacology. Mylinh areas of expertise and interests include large scale manufacture of monoclonal and recombinant protein using single use bioreactor, she also spent several years within the Supply Chain Management team at Murex Biotech and had first-hand experience with Lean Six Sigma for process improvement.
She later moved to CSIRO and helped to establish the CSIRO Tissue Culture Facility and more recently was involved in the design/ establishment/ qualification of a new manufacture clean room suites, CSIRO's new National Vaccine and Therapeutics Laboratory. Mylinh current interests are Environmental Monitoring; Contamination Control Strategy; Equipment and Process Validations and Phase Appropriate Manufacturing.
Mylinh is a committee member of the Parenteral Drug Association (PDA), Australian Chapter since 2018.
Pauline is a young professional with a background in biological science research and in the pharmaceutical industry. In her current role, she is involved in global Pharmacovigilance Excellence & Compliance, leading PV system improvement projects and supporting global and local PV compliance and processes. Previously, her role was in Quality Assurance and Manufacturing within a highly regulated manufacturing environment.
Her areas of interest include continuous improvement, project management, Pharmacovigilance and Regulatory Affairs. She is passionate about advocating for STEM opportunities for students and young professionals (SYP) and establishing a local SYP community through her role as previous president and current committee member serving the PDA SYP AU chapter.