Unique R&D Team Leader opportunity
Make a difference to Australian healthcare
Central Hornsby location
Australian Scientific Enterprise is leading provider of clinical pathology diagnostic products, including quality control material. We are 100% Australian owned and based in Hornsby, NSW. Our primary products are quality control materials which we provide to pathology laboratories throughout Australia, New Zealand, Asia and Europe. We also perform contract manufacturing of novel products for other large enterprises. ASE invests significantly in research and development for both in vitro diagnostics (IVDs) and contract work.
We are seeking an experienced leader to manage a small team of scientists in the development of commercially viable quality control materials to meet the demands of the global pathology testing market. This primarily entails the development of commercially viable products for registration (TGA) in domestic and international markets.
This is a full-time, permanent role in Sydney, NSW.
Main Duties and Responsibilities:
– Managing product development to support the strategic advancement of the business.
– Leading, supervising and managing a team of Scientists to develop new products whilst ensuring safety, quality and cost are appropriately considered.
– Taking the pivotal role in driving R&D from project commencement, through pilot stages and transferring to production.
– Ongoing development of the scientific team to expand the skills, expertise and knowledge of the business.
– Complex (non-routine) laboratory production requiring a high level of professional judgment, practical experience and scientific expertise.
– Driving process development and improvement.
– Development and improvement of Quality Management System documentation to support the production and development environment.
– Development of product registration documentation under the Therapeutic Goods Administration (TGA) framework.
– Generating and analysing product stability data to support the product Medical Device File (MDF) and TGA registration.
We are looking for an experienced leader that is practical, outcome-focussed and passionate about their work. The successful candidate will possess the following skills and experience:
– Demonstrated experience in a similar leadership role.
– Experience in the IVD industry or a related sector.
– Tertiary Degree in Chemistry, Formulation Science or a related field
– Working knowledge of regulatory and quality expectations such as TGA/FDA/CE guidelines.
– Working knowledge of the technology and current trends in the IVD industry.
– Demonstrated ability to approach and resolve problems systematically.
– Ability to work independently and demonstrate innovative skills to develop commercially viable products.
– Some understanding of biological degradation pathways and related chemistry is desired.
– Willingness and ability to learn from and share knowledge within the team.
If your experience, skills and educational qualifications fit this profile, please submit your application to Recruitment [at] ASEonline.com.au