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 a motivated Quality Control Operations Manager to join our growing team.
In this role, you will lead the day-to-day operations of the Quality Control laboratory, ensuring testing associated with cell therapy products is delivered efficiently, accurately and in compliance with GMP requirements. You will work closely with internal teams including Manufacturing, Quality and Supply Chain to coordinate testing schedules, support investigations, and maintain high standards of quality and compliance.
Reporting to the Analytical Systems & Technology Manager, this role plays a key leadership position within the Quality Control team, overseeing daily QC laboratory operations while guiding and mentoring QC Scientists and Shift Leaders and driving continuous improvement across the function.
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. This is a great opportunity to gain experience and get directly involved in the newest advanced therapies that can make a serious impact on patient’s lives.
What you will be expected to do
- Lead and coordinate daily operations of the Quality Control laboratory to ensure testing is completed accurately and on time.
- Manage QC laboratory scheduling and testing priorities to support manufacturing timelines and product release.
- Provide leadership, mentoring and guidance to Quality Control Scientists and shift leaders to support team development and performance.
- Ensure QC testing and documentation are performed in accordance with GMP requirements, SOPs and quality standards.
- Collaborate with internal teams including Manufacturing, Quality, Facilities and Supply Chain to ensure efficient workflow and operational alignment.
- Support investigations relating to deviations, non-conformances and out-of-specification results and assist with implementation of corrective and preventive actions (CAPA).
- Participate in internal audits and support preparation for external client and regulatory audits.
- Identify opportunities to improve QC processes, laboratory efficiency and testing practices.
- Support the implementation of new QC assays, technologies and laboratory procedures.
- Monitor laboratory resources and equipment to ensure efficient operation and minimal downtime.
- Promote a culture of quality, safety, continuous improvement and collaboration within the QC team.
Skills & Experience
We are looking for someone who brings both strong technical QC expertise and leadership capability.
Essential:
- A degree in Life Sciences (BSc, BAppSc or equivalent).
- At least 5 years’ experience working in a GMP-regulated environment, ideally within Quality Control supporting cell or gene therapy products.
- Hands-on experience with QC testing platforms such as flow cytometry, PCR, potency or safety assays.
- Strong understanding of assay validity, deviations, investigations and OOS processes.
- Demonstrated experience leading or mentoring teams in a laboratory or QC environment.
- Excellent organisational, problem-solving and communication skills.
- Ability to work effectively in a fast-paced and highly regulated environment.
Desirable:
- Experience working with PIC/S Annex 1 and Annex 2 requirements.
- Previous involvement in regulatory or client audits.
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.
If you believe you are a great fit, please apply now.
You will be directed to our recruitment portal to complete the application process.
*We will not be liable for any fees and cost associated with unsolicited CVs sent to us from recruitment agencies.
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.
To apply for this job please visit celltherapies.readycareers.io.
