The ISPE Australasian Affiliate is a legal entity chartered by the parent ISPE organisation in the USA. We are a registered not-for-profit company in Australia.
The Board consists of volunteer directors, all of whom are professionals in the industry. As a minimum, the Board meets every month and holds an annual general meeting, usually in December. Subcommittees are formed at the annual face to face meeting to focus on Stakeholder Engagement, Events, Communications and Corporate Governance.
Helen Atkinson, ISPE Australasia Affiliate President
Helen Atkinson has been working as a Senior Consultant with SeerPharma Pty Ltd for the past 15 years providing quality and GMP consulting to the life sciences industry. Prior to moving to Australia she was employed by Abbott Laboratories in a number of roles within QC and later Manufacturing, Science and Technology in the UK.
Helen is experienced in all stages of Human and Veterinary therapeutic product manufacture according to relevant current codes of GMP. Significant recent product experience includes aseptic and terminally sterilised products, radiopharmaceuticals and complementary medicines.
Helen has provided GMP and validation expertise to new facility design and build projects, including preparation and implementation of Validation Master Plans to meet both TGA and FDA requirements.
Helen holds a BSC (Hons) in Biomedical Chemistry from Sheffield Hallam University, United Kingdom.
Nick Patel, Treasurer
Nick is the Business Unit Manager- Radpharm Scientific for Global Medical Solutions Australia (GMS). His current remit includes P&L responsibility, business development and managing operations, engineering and quality team. Prior to moving to GMS, Nick has worked in Parnell Manufacturing Pty Ltd and Cadila Pharmaceutical Ltd in Validation and Production roles.
Throughout his career, Nick has been an instrumental player in a variety of successfully managed projects by utilising his strong project management skills, technical expertise and solutions oriented attitude; from the introduction of new pharmaceutical products to the market to the implementation of a commercial facility (including regulatory approval). Nick holds a Bachelor of Engineering (Chemical) and has completed his MBA from AGSM at UNSW Business School, Australia.
Stephen Firmer, Secretary
Stephen Firmer has over 25 years of experience in the pharmaceutical industry and is currently a Director of Asia Pacific Consultants Pty Ltd, an Australian based consulting group established in 1996 focusing on design and project management, operational and quality management support in the human and animal life science industries.
During his time with Asia Pacific Consultants he has assisted many organisations with quality system improvements, process design, facility design, commissioning and validation as well as with their training and GMP auditing requirements.
Prior to joining Asia Pacific Consultants, Stephen has held senior roles within industry including Multigate (Quality and Regulatory Affairs) and Roche (over 18 years including Technical Management, Production, Logistics and IT implementation projects) as well as within Government at the Australian TGA (Lead Auditor). During his career his work has taken him to many countries in the Asia Pacific region including projects in China, India, Bangladesh, Thailand, Malaysia, Philippines, Taiwan and Indonesia.
Stephen holds a PhD in Pharmaceutics, as well as a bachelor degree in Pharmacy (Hons) from the University of Sydney. As well as being a long term member of ISPE, he is also a member of the Association of Regulatory and Clinical Scientists (ARCS Australia).
Benjamin Sauer,Director (Past President)
Ben has over 15 years’ experience in the Pharma industry, predominately in technical services and operations management within TGA or FDA approved sterile fill and finish facilities. He is the current Site Technical & Portfolio Lead for AstraZeneca in North Ryde as part of the MLT.
Ben was previously the National Operations and Compliance Director for Global Medical Solutions (GMS) and Radpharm Scientific (2012-18) as part of the Senior Management team. GMS is a Manufacturer of aseptically produced radiopharmaceutical (SPECT and PET) unit doses, with facilities in Sydney, Brisbane and Perth. Radpharm is a Manufacturer of sterile fill and finish LVP, with the sole facility in Canberra. Here his remit included oversight of production processes and facilities, QA and Regulatory Affairs, logistics, & engineering - including their respective P&L.
Prior to GMS/Radpharm, Ben held the positions of Manufacturing Manager for Parnell Life Sciences (2010-12) and Project and Validation Manager for Jurox Pty Ltd (2006-10). His expertise include facility and clean room design and operation, HVAC (clean room and containment), sterilisation process (moist/dry heat), process improvement, lean six sigma and operational excellence. Previous experience include Bioanalytical Chemistry and Research and development (e.g., method development/validation and product development).
Ben holds a PhD in Bio-medicinal Chemistry, as well as bachelor’s degrees in Science (Hons) and Environmental Science.
Romit Singh, Director
Romit Singh completed a Master of Science (Honors) Good Manufacturing Practices at Swinburne University of Technology (VIC) in 2007. Additionally, he has been successful in achieving a Master of Science in Biotechnology and Bachelors in Chemistry in India.
Romit has held some Quality Assurance and Regulatory Affairs positions within the Australian healthcare sector varying between veterinary, OTC and medical devices manufacturing. He is also trained by the TUV as an internal auditor for ISO 13485:2003. He has been an ISPE Member for close to 5 years and previously held the position of the President for Swinburne University of Technology Student Chapter of ISPE until 2011, looking after engaging the bio-science students with the industry and ensuring the growth of the Chapter. Romit now holds the role of ISPE Director.
Romit is currently a member of ARCS and RAPs, and has a great passion for regulatory affairs and manufacturing.
Maurice Parlane, Director
Maurice Parlane is Principal/Director of New Wayz Consulting Limited, a New Zealand based consulting group focussed on improving quality, operational and business performance for clients in the human and animal life science sectors.He has been in consulting practice for 18 years during which time he has assisted numerous organisations to establish, improve or scale-up manufacturing or supply chain operations in Australasia and the Asia Pacific region.
Prior to establishing New Wayz; Maurice held senior engineering and manufacturing roles within the Glaxo group of companies in New Zealand.He is a professional engineer, holding a Bachelor of Manufacturing Technology (Hons) as well as mechanical and electrical engineering qualifications.Maurice is the immediate Past President of the ISPE Australasia Affiliate, Past Chair of the Asia Pacific Affiliate Council and is active on a number of regional and international ISPE committees.
He holds professional membership of IPENZ, the Institute of Professional Engineers of NZ, and a the NZ Institute of Food Science and Technology.Maurice is the current chairman of the NZ Therapeutic Products Manufacturers Association and a member of PDA and NZBio.
Shane Bourne, Director
Shane is a Senior Manager Validation at the Seqirus (formerly CSL) Parkville site. He has worked in the pharma industry for 18 years ranging from R&D analytical development, API manufacturing, through to pharmaceutical development and manufacture. He has been involved in the area of validation for 15 years spanning equipment and process validation, tech transfer and new product introduction.
Kerry Dranganoudis, Director
Kerry has 30 years experience in the Pharmaceutical industry in Australia, England and the United States and is the Director and principal consultant of Compliance Connections consulting.