Biochemist - Quality Officer

3 days ago

Albany, Australia Vitaltrace Full time

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

- 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)

About Company

About VitalTrace

VitalTrace Pty Ltd is a multi-award-winning, VC-funded Australian-based Med-tech start-up company aiming to improve outcomes for mothers and children during the childbirth process. We are doing this by developing novel cutting-edge biosensor technologies for fetal monitoring during childbirth. We believe that mothers and babies deserve the highest standard of care, and that childbirth monitoring should be accurate and allow clinicians to make informed and timely decisions. We have a vibrant culture with a diverse, high-performing multidisciplinary team of clinicians, researchers, engineers, chemists, software developers, and data scientists all working towards the same goal.

This job is posted from Workinitiatives platform.

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