Quality Control Scientist – Shift Leader

About 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 a motivated and experienced Quality Control Scientist – Shift Leader to join our Quality Control team at our state-of-the-art Melbourne facility within the Peter MacCallum Cancer Centre in Australia's most dynamic biomedical precinct. This role will 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.

This is a full-time hands-on technical role located combining Quality Control testing with day-to-day shift leadership. You will perform testing of cell therapy products while acting as a key technical resource for the team, providing guidance and support to other Quality Control Scientists and helping ensure testing activities are completed safely, accurately and in accordance with procedures and Good Manufacturing Practice requirements. You will provide technical leadership on shift, using your experience to support colleagues, troubleshoot issues and help foster a collaborative, quality-focussed and continuously improving laboratory environment.

What you’ll be doing

As a Quality Control Scientist – Shift Leader, you will:

- Perform quality control testing of human cell therapeutics according to the written procedures of CT;

- Prepare biological specimens and reagents, accurately document testing activities and support the timely testing and release of products to meet clinical needs;

- Act as a technical point of contact on shift,



providing practical guidance to other Quality Control Scientists across laboratory procedures and equipment within your areas of expertise;

- Identify, escalate and help troubleshoot equipment, assay and procedural deviations in collaboration with the Quality Control Operations Manager;

- Support investigations into non-conformances and out-of-specification results, as well as corrective and preventive actions and continuous improvement initiatives;

- Contribute to the review, development and update of standard operating procedures and other controlled documentation;

- Support equipment calibration, maintenance and commissioning activities to ensure critical laboratory standards are maintained;

- Use your technical knowledge and experience to identify opportunities to improve laboratory processes, equipment efficiency and ways of working;

- Foster a supportive and collaborative environment, encouraging problem-solving, continuous improvement and knowledge sharing across the team; and

- Ongoing training and development in all areas associated with quality control testing of cell products.

About You

You will bring solid hands-on laboratory experience together with the confidence to provide technical guidance and support to others.

Skills & Experience

Essential

- A Degree in a life sciences discipline or equivalent industry experience;

- Minimum 2-5 years’ laboratory experience within research, pathology or Good Manufacturing Practice environment;

- Experience in at least two of the following areas: flow cytometry, qPCR, cell culture or cell-based assays including ELISA;

- High level of accuracy, technical capability and attention to detail, with a diligent and quality-focused approach;





- The ability to identify procedural or Good Manufacturing Practice deviations and proactively raise and help resolve issues;

- Experience with laboratory equipment calibration, maintenance or commissioning, together with the practical aptitude to troubleshoot technical issues;

- Strong knowledge of established and validated Quality Control methods, including flow cytometry and validation of assays used for clinical and commercial products;

- Sound decision-making skills within your area of responsibility;

- 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;

Desirable
- Experience working in a Good Manufacturing Practice environment;

- Experience in method development and validation of Quality Control assays;

- Experience across testing platforms such as flow cytometry, PCR, ELISA and safety testing;

- Experience manufacturing or testing human cell therapies; and

- Knowledge of cell therapy testing techniques such as cryopreservation, safety testing, cell counting and other cell-based assays.

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're excited by the opportunity to combine your Quality Control expertise with hands-on technical leadership in a growing cell therapy environment, we'd love to hear from you.

When applying, please submit a CV and cover letter addressing the key requirements of the role.

Employer questions

Your application will include the following questions:

- Have you worked in a role which requires a sound understanding of Good Manufacturing Practices (GMP)?

- Which of the following statements best describes your right to work in Australia?

- How many years' experience do you have as a Quality Control Scientist?

- Have you completed a qualification in science?

- How many years' experience do you have in a quality control (QC) role?

- What's your expected annual base salary?

- How much notice are you required to give your current employer?

📌 Quality Control Scientist - Shift Leader (Melbourne)
🏢 Cell Therapies
📍 Melbourne