Senior Quality Control Analyst - Supply Chain Lead

Who We Are

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.

The evolution of Cell Therapies Pty Ltd will continue through its commitment to supporting local and international research and development activities in addition to a pipeline of new commercial contracts supplying Australian and International patients.   

About the Role

Reporting to the Chief Operating Officer, the Senior Quality Control Analyst - Supply Chain Lead is responsible for leading and coordinating supply chain activities to support timely material release. The role provides hands-on technical support through QC sampling, preparation and testing activities, while overseeing testing status, documentation completeness, inventory control and material flow in accordance with approved procedures, quality policies and cGMP requirements.

This full-time position is 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

• Plan day-to-day QC supply chain workload, including hands-on participation in QC sampling, preparation and testing activities
• Coordinate and monitor QC sampling, collection, preparation, testing status and material flow to support timely material release
• Support QC release processes by performing, tracking and reviewing laboratory testing activities, identifying delays and escalating issues in line with established procedures
• Prepare, review and maintain accurate QC documentation, laboratory records, logs, reports and tracking tools to meet operational and regulatory requirements
• Control and monitor the quality and quantity of QC materials, reagents and laboratory supplies through usage monitoring, reconciliation and record keeping
• Develop, draft and update SOPs and documentation relating to laboratory testing, sampling and supply chain activities
• Support the maintenance of cGMP-compliant quality systems through participation in audits, inspections, deviations and change controls, including provision of technical laboratory data
• Liaise and communicate effectively with Manufacturing, Quality Assurance and Project teams to ensure alignment of QC supply chain activities with laboratory testing and production schedules
• Provide technical support, guidance and training to staff on QC supply chain procedures, documentation standards and correct equipment use
• Contribute to continuous improvement initiatives to enhance QC supply chain processes, documentation and tracking systems

Skills & Experience

Essential

• Bachelor’s degree in life sciences (BAppSc or BSc) or equivalent industry experience;
• At least two years of previous experience working within a CDMO environment and associated client interactions;
• A professional and confidential approach to patient care and laboratory or testing services;
• Demonstrable ability to work and communicate cooperatively in a multidisciplinary team;
• A diligent and quality-driven approach; 
• Ability to multitask and work autonomously as well as in teams;
• Willingness to work shifts and weekends as necessary.

Desirable

• Expert knowledge of method development and validation of QC assays as applied to clinical and commercial phase products;
• Highly proficient in QC testing platforms as related to cell therapy products e.g. flow cytometry, PCR, ELISA and safety tests;
• Proficiency in cGMP standards and manufacturing under aseptic conditions.
• Recognised technical training and competence in quality control and material release support;
• A working understanding of medical microbiology concepts relevant to product safety and quality oversight;
• Familiarity with equipment maintenance, calibration coordination and associated technical documentation;
• Demonstrated communication, negotiating and decision-making skills;
• Demonstrated decision making ability;
• Strong analytical and reporting skills, with the ability to interpret data from multiple sources to support quality monitoring and escalation.

This is a great opportunity for a driven, collaborative and curious professional to join an organisation with purpose, passion for excellence and the aspiration to be a global leader in cell and gene therapy.

At CTPL we are passionate about the work we do but equally passionate about our people. We want everyone to bring their true self to work. We support the wellbeing of our staff through mindfulness sessions, continuous improvement activities and 5 wellness days a year.

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.

For additional information please see our website at www.celltherapies.com

Right to live and work

You must have the right to live and work in this location to apply for this job