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PDA Australia Chapter

President: Micheal Schafferius

Sartorius- Stedim

Overview

Welcome to the PDA Australia Chapter.

We are a part of a respected international community of scientists leading the way in the advancement of pharmaceutical technology. Connecting people, science and regulation is PDA's global mission.

PDA membership will allow you to:

  • Connect with other members via PDA Conferences and PDA Connect®
  • Access to the latest research and news
  • Attend Australian PDA Chapter events at a discount to the non- member price
  • Interact with industry leaders and representatives from global regulatory agencies
  • Increase your scientific and regulatory knowledge

To be added to the mailing list for notification of future events, please contact the Chapter President or any member of the PDA Australia Chapter Committee.

Current PDA members can also join us at our PDA Connect® page.
 

Thank You to the Current Chapter Sponsors

PDA Asia Pacific Events

 

PDA Signature Events

 

Officers

Executive Committee

President

Micheal Schafferius
Sartorius-Stedim

President-Elect
Justine Mann
CBE
Secretary

Maria Mylonas 
PharmOut Pty Ltd. 

Treasurer

Jo Sherriff
SeerPharma Pty. Ltd.

Members at Large

Usha Gullapalli
Communications and Memberships

Committee Members

Mark Dickson
CSL Behring

Mylinh La 
CSIRO

Justine Mann
CBE Pty Ltd.


Gerry McKiernan
Cell Therapies Pty Ltd.

Jo Sherriff
Seerpharma Pty Ltd.

David Spaulding
Seerpharma Pty Ltd.

Paul Kerr
SeerPharma Pty. Ltd.

Immediate Past President

Lisa Bennett
SeerPharma

 

About Us

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.

Justine Mann, President-Elect
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.

Jo Sherriff, Treasurer
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.

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.

Lisa Bennet, Immediate Past President

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). 

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.

Paul Kerr, Committee Member
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.

 
 

Get Involved

The Australian Chapter is an extension of the PDA international non-profit organization. The local Chapter focuses its efforts towards organizing and providing local events targeted at pharmaceutical/biopharmaceutical industry members, especially those involved in the development, manufacturing, quality control, quality assurance, and regulatory affairs.

The Australian Chapter of the PDA is comprised of volunteers from a variety of local industry organizations and is made up of Chapter Officers that comprise of the Executive Committee and Committee Members. The Australian Chapter aims to run one major event with the TGA annually and additional seminars throughout the year. The objective of these events is to provide industry professionals with a venue and platform to converse and exchange information while enjoying presentations from the top industry professionals.

The Australian Chapter aspires to be an integral link in education and is always looking for new volunteers who may assist us in our efforts. Your support, comments, and suggestions are the mechanism to our improved success.

For additional information, please contact the chapter at [email protected].

 

Presentations

This page contains presentations from past meetings.

Note: TGA presentations given at our events are available on the TGA website.

 
 

Student Chapter

The PDA Australia Committee is delighted to announce that we have set up a Students and Young Professionals (SYP) part of the PDA Australia Chapter.
The mission of the PDA Australia SYP shall be:

  • To develop future leaders in the applied life sciences.
  • To establish a culture of life-long learning and professional development.
  • To foster stronger relationships between students/young professionals and pharmaceutical and biotechnology professionals.
  • To exemplify the purpose of PDA including promoting the sciences of pharmaceutical technology and high standards for products of the pharmaceutical industry with emphasis on parenteral technology, sterile products, and related processes.

We are thrilled to have the following people in SYP mission-control and will be fully supported by the PDA Australia Chapter:

 

Student Chapter Officers

Student Chapter President

Pauline Deng

Pauline graduated from the University of Western Australia, majoring in Biochemistry and Molecular Biology, and completed her Honours in Pharmacology. She is an alumni of the CSL Graduate program and currently working in Global Pharmacovigilance for CSL. Pauline has held previous roles in Quality Assurance, continuous improvement, and project management. She enjoys continuously learning within the different areas of the pharmaceutical industry and is very passionate about advocating opportunities for the next generation of STEM leaders!

Student Chapter President-Elect
Adam Alhuwaider 

Adi is currently a Senior Research Assistant at St. Vincent’s Institute of Medical Research in the Recombinant DNA Repair group, working on a collaborative oncology project with Pfizer’s Centre of Therapeutic Innovation. He has joined the pharmaceutical industry at CSL shortly after finishing his Ph.D. in Biochemistry, specifically protein function in health and disease. His studies and technical skills have provided the background needed for the scale-up development work in R&D for the different CSL drug products, and in medical research. Adi is keen to develop and learn about various aspects of the pharmaceutical industry, starting from Drug Design and Development, to Quality Control and Quality Assurance.

Student Chapter Immediate Past President

Selda Yildiz-Kaya

Selda has around 9 years of experience in working for some of the largest pharmaceutical companies in Turkey and Australia. Selda is currently working as a Senior Quality Assurance and Compliance Associate at CSL Behring in Melbourne and assisting with Regulatory Inspections.  She has had various roles within Engineering and Quality departments previously. Selda is a Chemical Engineer and has a Master’s Degree in Business Administration. She is passionate about any learning experience that offers a different perspective and promotes continuous improvement at workplace.

Student Chapter Treasurer

Rebecca Seneviratna

Rebecca is currently a research scientist at the Peter Doherty Institute for Infection and Immunity in the Godfrey laboratory, where she investigates the development and function of unconventional T cells in diseases such as Merkle cell carcinoma, prostate cancer, malaria and more recently, COVID-19. Rebecca is a science honours graduate and qualified Australian lawyer, who prior to working in academia, was a senior project officer for the federal government and a junior lawyer. Rebecca is very interested in the intersection between academic research and industry and has been selected to participate in The BridgeTech Program 2022.

PDA Australia Student Chapter "FInd Your Future In STEM" Photos

PDA Australia Student Chapter

(l-r) Shauna Herbst, Bonnie Seymour, Srujana Mokka, Selda Yildiz Kaya (SYP President), Pauline Deng (SYP Vice President) and Polly Sabljak

PDA Australia Student Chapter

(l-r) Adi Alhuwaider (SYP Treasurer) and Charlie Ma (SYP Secretary)