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 experienced Manufacturing Scientist Manager to support the delivery of aseptic cleanroom manufacturing activities for cellular therapeutics in accordance with cGMP requirements, regulatory guidelines and clinical needs.
In a typical week, you will coordinate and support GMP manufacturing activities for cellular therapeutics, provide technical guidance and training to Manufacturing Scientists, complete and review manufacturing documentation, support investigations and process improvements, and work closely with cross-functional teams to ensure safe, compliant and efficient manufacturing operations.
This position located at our 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.
What you will be expected to do
· Manufacture cellular therapeutics in accordance with cGMP requirements and clinical timeframes
· Ensure manufacturing activities are performed in accordance with approved SOPs, batch records and quality requirements
· Accurately complete manufacturing, testing and quality documentation in line with CTPL and cGMP standards
· Investigate and document non-conformances and out-of-specification results, and support CAPA activities in accordance with CT procedures
· Support validation activities for new processes and equipment
· Assist with manufacturing scheduling, forecasting and document preparation
· Monitor materials and equipment usage and assist in resolving operational issues impacting efficiency or downtime
· Provide technical training and guidance, and day-to-day support to the manufacturing team
· Support implementation of new manufacturing processes and operational improvements
· Participate in training, clinical and scientific meetings
· Work collaboratively across multidisciplinary teams to support operational and organisational objectives
Skills & Experience
Essential
- Bachelor’s degree in life sciences or related discipline, or equivalent industry experience
- Minimum 2-3 years’ experience working with human cells, tissues, plasma and/or blood products, preferably within cleanroom environments
- Knowledge of aseptic processing, cell culture techniques, cryopreservation and associated analytical methods
- Experience preparing GMP documentation including SOPs, batch records and forms in line with TGA/FDA regulatory requirements
- Ability to identify deviations and contribute to continuous improvement initiatives
- Strong technical capability, attention to detail and ability to work effectively within multidisciplinary teams
- Ability to manage competing priorities and work both autonomously and collaboratively
- Professional approach to quality, confidentiality and patient-focused service delivery
Desirable
- Experience delivering Human Blood & Tissue cGMP compliant services
- Experience with small or large-scale aseptic cell culture handling and biopharmaceutical manufacturing
- Proficiency in systems such as MS Office, BMS/EMS and LIMS
- Understanding of Medical Microbiology
- Demonstrated research and analytical skills, including the ability to use data to provide recommendations to senior staff
- Support OH&S initiatives and promote a safe and healthy workplace
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!
Job Types: Full-time, Permanent
Pay: $120,000.00 – $130,000.00 per year
Benefits:
- Professional development assistance
- Referral program
Work Location: In person
