OUR TEAM
CEO
Justine Mann
BAppSc, MBA
Justine has 25 years technical and management experience in Quality and Manufacturing in MTP industries and has worked on assignments in USA, Europe and Asia. Formally, a Senior Director Quality Operations for ANZ/India at Hospira/Pfizer. Justine has extensive management experience and provided technical and operational leadership to ensure site compliance in accordance with US FDA, EU-TGA-PICs regulations and standards. Justine will oversee the operational aspects of the business, ensuring that systems are in place for the commencement of manufacture and microbiological testing.
“Contributing to MTP has driven my career, I am passionate about translating and generating medicines onshore that can profoundly impact human and animal healthcare and improve our national sustainability”
OPERATIONS MANAGER
Robyn Hofer
BASci
Robyn has almost 20 years extensive pharmaceutical experience within the QC Laboratory. Robyn has a proven ability to ensure compendial and regulatory compliance and establish quality systems. Robyn has experience in co-hosting and participating in TGA, FDA and ANVISA regulatory inspections and customer audits and is yellow belt certified. Additionally, Robyn is a skilled change agent in challenging, influencing and supporting departmental practices, policies, systems, attitudes, and structures.
QUALITY MANAGER
Andrew Hoxey
BAppSc, MSc
With over two decades of experience in Quality Management, Andrew Hoxey is a highly skilled professional in the field. His expertise lies in quality manufacturing within the pharmaceutical industry, with deep experience in sterile injectable, vaccine, and medical device. Throughout his career, Andrew has designed and conducted quality audits, assessing compliance with various regulations including US FDA, EMA/MHRA and TGA-PIC/s, as well as local and international standards. His auditing experience extends globally, including Africa, the USA, Europe and Asia, with a focus on India. Andrew has prepared businesses for regulatory audits and supported uplift to address identified gaps and opportunities.
BUSINESS DEVELOPMENT MANAGER
Wayne Adcock
BApSci, PhD, Post Grad Dip BA
Wayne is biologics/pharmaceutical leader with over 25 years of experience in Manufacturing, Quality, R&D, Continuous Improvement and Contract Management. Wayne has a reputation for having an energetic and pragmatic leadership style with strong interpersonal relationship skills and a strategic approach to delivering outcomes. Wayne has experience across multiple regulated industries: biologics, sterile pharmaceutical, medical device, supply chain and quality and has developed strategic solutions to operations, regulatory and compliance challenges (TGA, ISO, DoH, FDA, PICs).
CHAIR OF THE BOARD
Jeff Davies
BSc(Hons) PhD
Jeff is a Biopharmaceutical Executive with over 40 years industry experience. As CSL’s Executive Vice President and General Manager for Asia Pacific, he had oversight and lead the plasma products, influenza vaccines, antivenoms, in-licensed vaccines, pharmaceuticals and the diagnostic businesses. This included oversight of major infrastructure projects for clinical trial and biological production facilities to TGA/FDA standards. He was a member of the due diligence team that resulted in CSL becoming a global company and prior to his GM roles was Global Head of Research and Development for CSL Behring, with oversight of R&D strategy and translation programs from R&D to commercialisation.
Jeff has held a number of senior advisory roles, including sitting on the Pharmaceutical Industry Council, the Australian Red Cross Advisory Board and Medicines Australia and other Board roles.
"I am excited to be part of CBE Pure Solutions: a company striving to provide essential infrastructure to support onshore development and manufacture of new medical therapies and diagnostics targeting global market.”
BOARD MEMBER
Steve Williams
BSc, Grad Dip QM
Steve has over 45 years experience in quality and manufacturing, including 30 years in GMP Quality Management and Regulatory Compliance for major Biopharma firms. He has developed multiple GMP training courses (GLP, Process Validation, Risk Management, Sterile Manufacture and Quality Management Systems) and will oversee development of the Quality Management System and training.
“After a career of over 50 years in the industry, I am passionate about supporting companies to realise their medical product assets. CBEPS aims to be a like-minded partner, dedicated to using our capabilities to support the Australia and more broadly the Asian ecosystem. We have aligned our operations, processes and quality system to enable us to deliver reliable manufacturing and testing services to support our customers to bring products to their patients.”
BOARD MEMBER
Andrew Watson
BEng
Andrew has designed, constructed, qualified and operated cleanrooms over 25 years. As independent chair for Standards Australia ME-060 (Controlled Atmospheres), Andrew is the Australian recognised expert in cleanrooms and provides his expertise writing international standards. Andrew will oversee the project and ensure that the facility is designed, constructed and qualified to the required standards and build a sound strategic future for the business.
“CBE Pure Solutions embodies decades of experience in this industry. Our facilities, our processes and our approach to compliance respond to our vision - delivering the next generation of Life Science manufacturing.”
BOARD MEMBER
Andrew Carter
BSc, Grad Dip Bus, MCommLaw, AICD
Andrew is the founder and Managing Director of Commercial Eyes Pty Ltd and has over 30 years’ experience working in the health technology industry. Headquartered in Melbourne and employing over 110 people, Commercial Eyes has grown to be one of the foremost health technology commercialisation firms in Australia.
In addition to Andrew’s leadership and industry experience, he is a highly qualified and skilled company director, with over twenty years of governance experience in the private and not for profit sector.
Andrew is a director of three private companies, Deputy Chair of Rare Voices Australia (national peak body for Australians living with a rare disease) and a member of the Invest Melbourne Advisory Board. He is past Chair of ARCS Australia, BioMelbourne Network and Melbourne City Mission.