AddressAbout the Company
Cell Therapies Pty Ltd (CTPL) is an incorporated Australian Proprietary Company which manufactures and deploys advanced cell-based therapies to the global cell and gene therapy (CGT) market.
As a business, we are contracted by other companies to develop and manufacture their innovative products for Australian and international patients. In the last 15+ years, we have established our excellence in the field and are now acknowledged as an industry leader in delivery of these ground-breaking treatments to patients.
About the Role
We are seeking motivated Quality Control Analysts to support our facility and product manufacturing teams who manufacture clinical and commercial cellular therapy products in compliance with the Australian Code of Good Manufacturing Practice.
These full-time positions are located at our new state of the art Melbourne facility located at the Peter MacCallum Cancer Centre on the edge of the CBD in Australia's most dynamic biomedical precinct.
We are recruiting for individuals starting their QC career within this exciting Biotech space through to a more senior Analyst with more than 5 years’ experience.
What an Analyst will be expected to do:
- Successful Quality Control testing of human cell therapeutics according to the written procedures of CT.
- Collecting information related to the human blood & tissue samples collected by the Production Team and testing those cell samples to meet Quality Control standards.
- Establishing new methodologies / techniques or assays as required – for more experienced candidates.
- Research and analytical skills, including using a variety of data sources to provide advice and recommendations.
- Maintenance and support of the cleanroom and laboratory activities of CT associated with clinical or commercial manufacturing.
- Execute testing as defined in validation protocols as related to activities within Cell Therapies including method transfer, method development and method qualification.
- Participation in the maintenance of cGMP compliant quality systems as audited by the Therapeutics Goods Administration.
- Developing, drafting, updating and authoring SOPs and other documentation.
- Effective and professional communication with other CT staff.
- Ongoing training and development in all areas associated with Quality Control testing of cell products.
Skills & Experience
Essential:
- A Degree in a life sciences discipline or equivalent industry experience;
- High level of accuracy, technical capability and attention to detail;
- Ability to multitask and work autonomously as well as in teams;
- A diligent and quality-driven approach;
- A clear and confident communicator in a multidisciplinary team;
- Minimum 2-5 years’ experience in a Laboratory (Research, Pathology or GMP); and
- Experience in one of the following areas flow cytometry, qPCR, cell culture, cell based assay including ELISA;
Desirable:
- Experience in a GMP environment.
The salary offered will be commensurate with skills, experience and industry standards. Company specific GMP training will be provided as part of the induction process.
If you think you have what it takes to be part of a dynamic team for a company that is in a very exciting growth phase, then APPLY NOW!
Applications, including a CV and covering letter addressing the key requirements of the role, should be submitted via "Apply for this job" link below. Please note that only applications received through this link will be considered.
