Micheal Schafferius, President
Micheal has worked in the pharmaceutical and biopharmaceutical industries for more than 15 years. His experience includes roles focused on Filtration, Single-Use Technologies, Quality Assurance, Validation and Sterile Manufacturing with local and international companies. Currently, Micheal is a specialist for filtration and quality at Sartorius Stedim Biotech.
Eoin Hanley, Immediate Past President
Eoin is currently a Quality Assurance Compliance Manager with CSL Behring. Eoin has worked in the pharmaceutical & biotech industries in Europe, the USA, and Australia/Pacific, with some of the largest companies in the world. He has experience in a variety of roles within Quality, Engineering, Qualification/Validation and consulting. Eoin has worked on a range of products from API's to sterile medicinal products, including blockbuster recombinant proteins. Eoin’s experience comes from a background in Analytical Chemistry and an MSc. in Pharmaceutical Validation. He also has a passion for keeping up to date with current regulatory and industry trends, as well as the application of lean and operational excellence approaches.
Paul Kerr, Treasurer
Paul is a Partner of SeerPharma and has over 35 years of broad pharmaceutical experience across various technological areas (scientific and IT) as a qualified chemist and an IT project manager. Paul is a qualified PDA Software Supplier Auditor and conducts IT gap analysis and compliance audits for companies. Paul is experienced in computer validation and assists companies in establishing IT compliance and computer validation programs. He has been a valued member of the PDA for many years and served on the Australian committee since 2004.
Maria Mylonas , Secretary
Maria is the Head of Learning and Development at PharmOut. Maria has over 20 years’ experience in Quality Control, Quality Assurance, and Learning & Development management roles in the Pharmaceutical, Medical device, and Automotive industries in the Asia Pacific Region. She is a qualified Biological Scientist and educator and routinely trains sector in a wide range of GMP topics, including current PIC/S updates, Data Integrity, Quality Risk Management, CAPA, ISO 13485, to name a few. Maria is passionate about program design and competency assessments that align with business strategy and quality culture.
David Spaulding, Committee Member, and Past President
David has over 35 years’ experience in the pharmaceutical and dental industries, in Research and Development, Logistics Management, Training, Manufacturing (including aerosols, sterile and non-sterile dosage forms) and Sales and Marketing. He has also owned and managed small to medium-sized pharmaceutical companies, specialising in delivering substantial growth and technical expertise. David is currently a senior consultant with SeerPharma Pty. Ltd.
Mark Dickson, Committee Member
Mark Dickson is a Director, Quality Assurance Compliance, at CSL Behring Broadmeadows. Previously a Senior Global Quality Manager at Novartis International AG managing significant-quality incidents and escalations for Novartis Technical Operations and performing GxP audits on behalf of the Pharma QA Compliance & Auditing Group. He also provides expert GMP advice to Pharma QA, assisted in GMP training, supported global commitments, and continuous improvement initiatives. Mark previously worked for the Therapeutic Goods Administration (TGA), Office of Manufacturing Quality (OMQ) for 8 1/2 years. Prior to the TGA, Mark worked for 13 years in both quality and manufacturing roles within the pharmaceutical industry.
Usha Gulapalli, Committee Member
Usha has more than 25 years of experience in the Pharmaceutical Industry and with a proven record of accomplishment of building and leading teams/organizations that deliver results. Over the course of her career, she has demonstrated flexibility and the ability to quickly learn new skills in successfully switching between R&D, Quality and Operations. Usha believes that everyone in an organization has the ability to “Make a Difference” through a culture of accountability and open communication. She has been successful in driving this type of culture and her group has been recognized as the highest performing team in the organization. As a committee member, Usha brings great passion for the knowledge sharing and networking that the Australia Chapter encourages.
Mylinh La, Committee Member
Mylinh is a biomedical scientist with over 20 years of experience working in both the academic environment as well as the biotech industry. Mylinh gained her Ph.D. at the University of Melbourne (Department of Pharmacology). Mylinh left for the industry and joined Murex Biotech Ltd where she spent several years with the Monoclonal antibody Team. She later moved to the Supply Chain management team within the company, overseeing production planning. In 2009, Mylinh returned to Australia and joined the Department of Pharmacology at Monash University as a Senior Research Fellow before moving to CSIRO in 2010. Mylinh is currently the laboratory and production manager of the mammalian CSIRO Tissue Culture facility (CTCF).
Justine Mann, Committee Member
Justine Mann is a Director at CBE Pty Ltd. Justine has over 20 years of experience in the pharmaceutical industry as a Quality Operations Director and Technical Operations Manager.
Justine has had responsibility for providing technical, operational, and strategic leadership to ensure compliance in accordance with US FDA, EU-TGA-PIC/S regulations and local and international standards. Justine specialises in developing strategic quality plans and risk management plans, focusing on remediation strategies, quality enhancements and process improvements for operational efficiency. Combining a Microbiology background with an MBA specialising in business management and leadership, Justine works with clients to provide strategic and compliant solutions.
Gerry McKiernan, Committee Member
Gerry McKiernan heads QA, QC, validation, and Quality consultancy projects for Cell Therapies Pty Ltd and its affiliated units at the Peter MacCallum Cancer Centre. Gerry has 20 years' experience in Quality roles in product development and GMP clinical and commercial manufacturing in Europe, Australia and Asia across biotechnology, pharmaceutical, medical device and cell, and gene therapy industries.
Jo Sherriff, Committee Member
Jo, currently a Senior GMP Consultant at SeerPharma Pty Ltd, is an experienced senior compliance engineer and senior consultant with 20 years of experience within the pharmaceutical and life science industries. She is not only a qualified Chemical Engineer but also a specialist in the development and execution of GMP validation documentation, GMP Design Reviews, and development of Quality Systems. She also has extensive experience with non-GMP facility compliance, TGA, FDA, DAWR Biosecurity), OGTR, ARPANSA, SSBA, and Pharmacy Board of Australia, SHPA, PRASA compliance. Jo is also an experienced presenter of Validation Workshops, GMP Training and conducts Quality Assurance Audits.