- FDA Approved
- Management Team
Our client is a Melbourne-based, biotech company focused on empowering oral healthcare professionals and increasing the opportunity for preventative treatments globally. They have had significant growth towards translation and scale-up readying for commercialisation and entry into the US Market following FDA 510k Clearance in May 2023.
In early 2023, they launched their new manufacturing facility in Melbourne, Australia. This purpose-built facility, aligning with their values, supports direct manufacture, to expand the value chain and keep capabilities locally in Australia. Your role
Reporting to the CEO, the successful Head of Scientific Operations will ensure that their innovative manufacturing processes are well characterised and defined, and that the technology transfer of products from R&D is conducted methodically and thoroughly. You will:
- Oversee and control the scale up activities and ensure the plant and equipment purchased for the processing is fit for purpose and the process can be undertaken on a routine basis at various scales.
- Ensure efficient end-to-end manufacturing and analytics to ensure that the product routinely meets registered specifications and ensure that any manufacturing service and supply agreements are met.
- High level of experience in technology transfer and scale up of manufacturing processes.
- Bachelor of Science or other tertiary qualifications in sciences.
- Experience in process optimisation, troubleshooting and investigations management.
- Industry experience in a manufacturing environment.
- Strong working knowledge of cGMP, data integrity principles and Quality Management Systems.
- Experience in team development and management.
- Sound analytical skills and attention to detail.
- Excellent verbal and written communication skills - to all levels of the organisation.
- Highly desirable experience includes: biologicals, protein science, process development, medical device manufacture, analytical test development, investigations management, new Capex programs, validation and experimental design.
To join our client in this new and exciting opportunity, please email your cover letter & CV to Mark Thomas or Marilyn Jones at firstname.lastname@example.org. Confidential enquiries to Mark or Marilyn on 1300 0 MEXEC
Please note that the PD & title of the role will be subject to review upon the hiring of the successful candidate.