Are you an experienced scientist with a passion for troubleshooting, continuous improvement, and assay development? Our client, a global biopharmaceutical company is seeking an Immunoassay Scientist for a 12 months fixed-term contract to play a key role in ensuring the robustness and regulatory compliance of their immunoassays and bioassays.
Reporting to the ANZ Technical Manager, your key responsibilities will include:Troubleshooting & Continuous Improvement
- Provide scientific and technical support for Quality Control (QC) and Quality Assurance (QA) teams.
- Investigate technical assay issues, recommend solutions, and drive improvements.
- Conduct Analytical and Process Trend Analysis to enhance assay performance.
- Identify opportunities for analytical improvements to meet regulatory requirements.
- Support the Quality Control team in executing assay validation studies, offering expertise in analytical methods, instrumentation, and procedural optimization
- Work closely with Quality teams to prepare validation protocols and reports.
- Oversee the transfer of analytical assays from internal R&D teams or third-party laboratories.
- Prepare and maintain GMP documentation for assay transfers, including protocols, SOPs, quality standards, and validation reports.
- Liaise with all relevant teams for new product introductions and assay implementations.
- Degree (BSc, MSc, or PhD) in Biology, Biochemistry, Immunology, or a related field.
- Minimum of 3-5 years of experience working in a laboratory.
- A strong working knowledge in the analysis of proteins, viruses and bacteria using tools such as ELISA, Cell culture assays and virus infectivity assays.
- Hands-on experience with immunoassay and bioassay development, validation, and troubleshooting (e.g., ELISA, Luminex, MSD) in a pharmaceutical or academic setting
- A knowledge of GMP and regulatory requirements is desirable
- Ability to analyse data, identify trends, and implement process improvements.
- High attention to detail
- Excellent problem-solving skills and the ability to work across cross-functional teams.
If you are ready to apply your expertise to impactful biotech projects, we would love to hear from you. Please note that only applications submitted through the job boards will be considered. For a confidential conversation, please email Grace Bitodi on gbitodi@onqrecruitment.com.au.
