ABOUT THE COMPANY

Cell Therapies Pty Ltd (CTPL) is a commercial Contract Development and Manufacturing Organisation (CDMO) located within the Peter MacCallum Cancer Centre. We specialise in the development and delivery of cell and gene therapies and have more than 20 years’ experience in this area.
The growth of CTPL will continue through our commitment to supporting both Australian and international research and development activities, alongside delivery of commercial contracts to provide these highly personalised therapies to patients in Australia and the region.

ABOUT THE ROLE

We are seeking an additional Laboratory Assistant to support our Facility department with daily operations. This key role enables our manufacturing department to manufacture clinical and commercial cell based therapy products in compliance with the Australian Code of Good Manufacturing Practice.
As a Lab Assistant, your day-to-day will be filled with diverse and critical tasks. You will monitor environmental conditions in our clean rooms across multiple grades, manage daily cleaning and consumables restocking and maintain key lab equipment. Your role involves overseeing stock levels, assisting the Manufacturing team and ensuring adherence to all standard operating procedures and Good Manufacturing Practices. Additionally, your responsibilities will include supervising external contractors, handling liquid nitrogen, preparing shipments and supporting the logistics of patient products, including receipt of incoming materials and dispatch of final products to ensure timely and efficient production and delivery. With occasional shift and weekend work, each day brings new challenges and integral contributions to our facility’s operations.
This is a Full-time position 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.

DUTIES:

• Environmental monitoring (microbial and particulate) within clean rooms (Grade B) and Grade C/D environments using our standard operating procedures
• Supporting in daily Grade C cleaning in the facility
• Calibration and maintenance activities related to process equipment, safety cabinets, autoclaves, escorting external contractors and supervising them while performing any maintenance activities
• Supporting in stock management which includes stock counting, ordering and stocking the facility with general consumables
• Conducting daily top-ups with grade C garments, reagents and other consumables in Grade C/D environment
• Supporting Manufacturing team by performing monthly Biosafety cabinet cleaning, occasional after-use cleaning in the cleanrooms post-manufacturing, and supporting items transfer from Grade C to Grade B during active manufacturing
• Adhering to standard operating procedures and Good Manufacturing Practice
• Occasional shift and weekend work will be required
• Liquid nitrogen handling
• Preparing and packing materials for international and domestic shipping
• Assisting with the receipt of incoming patient products and the dispatch of final products in compliance with SOPs and regulatory requirements
• Supporting in writing non-conformance reports, CAPAs and Change Control Plans
• Establishing understanding a supporting facility paperwork review including documents like equipment logs, cleaning forms and logs