Principal Scientist - Diagnostics - qPCR

• Diagnostics - COVID & infectious diseases
• ASX listed -IVD
• World leading technology

Our Client
Our client is an Australian Biotechnology success story transforming molecular diagnostics. Their proprietary molecular diagnostics platform technology provides hospitals and pathology laboratories the ability to screen for a wide array of diseases and infectious pathogens with a high degree of specificity and with rapid high throughput. Their continued long-term goal is to target health conditions where faster and more accurate diagnosis plays a pivotal role in improving community health both in Australia and across the globe. Now is an exciting time to be joining our client as they undergo further expansion and provide their world leading Coronavirus COVID-19 testing products both locally and internationally.

The Opportunity
A technically outstanding molecular biology scientist, combined with proven expertise in molecular product development, your remit will be to provide guidance across the organisation. A trouble-shooter, with leadership capabilities to guide others, you will be the go-to person for supporting the management and team to deliver our clients products to the highest quality and timelines.

• Provision of technical guidance to the QC, R&D and production teams
• Assist with product development programs and provide guidance to staff
• Day to day assistance with the leadership of scientific team and activities
• Able to conceive of and manage product improvement projects to completion
• Superior understanding of methylation & related technologies; molecular biology, genetics, bioinformatics
• Support Quality Management System activities and assist with CAPA investigations as required
• Supervise and provide assistance to the R&D team for designated projects.
• Liaise with Regulatory Affairs Manager to ensure all product development activities comply with QMS and regulatory requirements including TGA, FDA, HC and IVDD.
• Conduct bench work for development of designated products
• Assist production team with troubleshooting and projects when required
• Communicate project progress and other relevant information to CEO/CSO and staff
• Assist the CEO in relevant aspects of the business where required
• Evaluation of new scientific opportunities
• Undertake R&D projects as required
• Assist with the operation of the scientific facilities generally
• Thorough knowledge and practice of good scientific practice
• Capable of adherence to scientific delivery timelines

Position Requirements

• Minimum B.Sc. PhD or Masters an advantage.
• Extensive experience in laboratory techniques with molecular biology, PCR, RT-PCR, ELISA, IVD
• Experience in IVDD & TGA requirements. FDA & EU - CE a definite advantage.
• Experience in CMC/medical devices/IVD/drug & product/assay development in the diagnostics/life sciences/healthcare/pathology markets.
• Excellent understanding of product development concepts and practices
• Experience in and understanding of the expectations of a commercial environment.

Our Offer
Our client offers an exceptionally dynamic and progressive work environment. This role is at the frontline of development of new innovative technologies. They expect, and provide, excellent professional standards and work ethics. As a valued member of this team, you will have the opportunity to demonstrate your talent and shape this exciting company.

If you are interested in joining our client in this exciting new challenge, please call Marilyn Jones on 1300 0 MEXEC for a confidential discussion and/or email your résumé with your cover letter to careers@mexec.com

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