Biochemist - Quality Officer

Responsibilities

• Investigating the chemical structure and function of enzymes and their impact on organs and tissues in humans and mammals with regards to in-vitro and in-vivo biosensor performance.
• Examining enzyme kinetic activity using the knowledge gained to create and develop new products, materials and processes.
• In collaboration with the biosensor team to develop methods for quality control of lactate enzymes and biosensor components
• Performing test methods for biosensor performance assessment, generating documentation and written work instructions, and reporting on experimental results.
• Performing statistical analyses on experimental data sets and providing informed interpretation of results.
• Training technicians to perform testing and quality control of lactate enzymes and associated components for the in-house biosensor prototyping
• Investigate and respond to lactate enzyme chemical formulation critical issues for design and risk management as part of the skills required of an enzyme chemist
• Managing the required documentation and records in VitalTrace’s electronic QMS (Quality Management System) for the progression of biochemistry (enzyme-related) experimentation and biosensor research and development, along with compliance to Good Manufacturing Practice and ISO 13485 Class III device requirements for FDA and TGA approval.
• Ensuring IP protection of developed methods related to lactate enzymes used in the biosensor component of the medical device as a skilled and responsible enzyme chemist.

Requirements

Skills and Experience

• Conduct and interpret laboratory tests including chemical analysis and microscopy.
• Procedures are undertaken using strict Quality Control (essential for Class 3 Medical Devices).
• Interdisciplinary team experience with biology, chemistry, computer science, engineering, and manufacturing.
• Trained and experienced in the use of microscopy, variety of laboratory instruments for investigating the chemical structure and function of (specifically) different proteins.
• Isolation of specific enzymes, hormones and metabolites produced by living cells.
• Understanding and experience with data analysis tools (i.e., Excel, Python) and statistical methods and analysis.
• Ability to be highly methodical, well-organised, and detail oriented.
• Ability to communicate scientific results to critical stakeholders.

Qualifications

• Bachelor’s degree in Chemistry / Biotechnology sciences/ Quality Management and other relevant fields
• Working rights in Australia

Pay Rate | $80,000 - $100,000 (AUD)