Head of Bioscience & IVD
MiniFAB requires an outstanding professional to lead their team of scientists in the development and transfer of biological assays into microfluidic, medical diagnostic products.
The Head of Bioscience / In Vitro Diagnostics will be accountable for successfully translating the biological components of our product development activities from early stage feasibility studies, to implementation of volume-manufacturing solutions. Typically, development projects focus on point of care molecular and immuno diagnostics, with a growing interest in cell based applications. This role will require strong leadership of the existing bio-translation team (BTT), and close collaboration with the product development (PD) engineers, new product introduction (NPI) engineers, and manufacturing teams as we bring on line a number of exciting new products in collaboration with our global client base.
Duties include but are not limited to:
- Daily coordination of development activities to support translation of molecular, immuno, and cell based protocols into MiniFAB’s bio-lab facility (duplicating client capabilities, and translation of protocols to new product platforms)
- Translation of molecular, immuno, and cell based procedures from development environment to high-volume manufacturing environment in collaboration with NPI and manufacturing resources, including responsibility for product verification and process validation activities
- Supporting manufacturing lines (technical consulting)
- Strategic development of MiniFAB’s bioscience capability to address immediate and future demands with respect to technology and capacity within a regulated framework
- Supporting sales and marketing activities with technical expertise
- Mentoring of bio-team and education of engineering teams in bio-related subjects
- Full responsibility for setting and managing the teams operating budget
Essential Skills and requirements:
- Extensive experience with developing in vitro diagnostic assays with firsthand experience of successfully transferring development output to manufacturing
- Minimum of an honours degree in biology, biochemistry, immunology, molecular biology, microbiology, or similar
- Extensive understanding of Good Manufacturing Practises (GMP) and Quality Management Systems (ISO 13485 would be ideal)
- Extensive understanding of Validation and Verification processes under a QMS
- Must be a hands-on problem solver and team player
- Proven ability to deliver projects to strict budgetary and time constraints
- An ability to manage key internal and external stakeholders
- Experience of successfully working in a multidisciplinary environment
- Team leader with extensive project management experience
- Excellent written and verbal communication skills, and ability to take initiative
- Strong commercial acumen
If your skills and experience match the above criteria, then please apply with your CV and covering letter in Word Format (No PDF Documents please).
Kindly note that due to the high number of applicants, only short listed candidates can be contacted.
Questions can be directed to Leah Creswick at Fuse Recruitment Melbourne on 0478 193 170.