Quality Control Senior Scientist

Alfred Health

Alfred Health is a leader in health care delivery improvement research and education. We are the main provider of health services to people living in the inner southeast suburbs of Melbourne from ambulatory to inpatient and home and community-based services. On 1 January 2026 Alfred Health will come together with Kooweerup Regional Health Service Peninsula Health Bass Coast Health and Gippsland Southern Health Service to create Bayside Health a newly merged health service with more than 22000 employees caring for a community of over 1.2 million Victorians. The new health service will provide people with the best possible care with services that support them throughout their lives. The merger will also strengthen our workforce providing new training education and career opportunities. Subject to final approval on 1 January 2026 all employees from the five health services will transfer to Bayside Health.

• 12-month fixed term position
• Full time (80 hours per fortnight monthly ADO)
• Medical Scientists Grade 3 Year 1-4 (RY9-RZ3)
• Alfred Health location
• Great staff benefits!

The Department

The Chimeric Antigen Receptor T-cells (CAR-T) Facility is a newly built cleanroom facility at the Paula Fox Melanoma Cancer Centre (PFMCC). The facility will manufacture innovative cell and gene immunotherapies for patient care in the context of clinical research.

The PFMCC CAR-T Facility will operate under the Good Manufacturing Practices (GMP) framework under a Quality Management System in accordance with current government regulations and other applicable standards including Alfred Health policies.

The CAR-T Quality Control (QC) Scientist will develop and establish analytical methods to support the manufacture of clinical cellular therapy products in the PFMCC CAR-T Facility. The QC Scientist will be a key member of the team for integrating research and development projects into GMP quality control test procedures (technology transfer).

The Role

• Establish new methodologies techniques or assays to evaluate the safety quality and efficacy of manufactured cellular products
• Participate in technology transfer and research and development projects
• Establish third-party vendors to validate and perform assays
• Establish perform coordinate and interpret tests associated with cell therapy including flow cytometry cell count and viability maintenance of cell lines for use in assays ELISA qPCR and other cell-based assays and environmental monitoring
• Participate in continuous improvement activities
• Participate in quality improvement activities in accordance with the Quality Management System including but not limited to internal audits equipment management non-conformance and out of specification investigations trending operational change plans
• Ensure compliance with cGMP PIC/S OGTR and relevant clinical regulatory requirements
• Use of a variety of computer-based applications (MS Word Excel PowerPoint Outlook eQMS BMS/EMS)
• Participate in and deliver training relevant to the role
• Flexibility to participate in planned operational tasks on weekends and overtime as necessary
• Participate in an on-call roster

Qualifications and Experience Required

Essential

• Bachelor of Applied Science (Medical Laboratory Science) or Bachelor of Science or equivalent. Where equivalent includes a degree awarded by an overseas tertiary institution which is recognised by the National Office of Overseas Skill
• Recognition which in the case of Medical Scientists is the Australian of Medical Scientists (AIMS). Background in Haematology Transfusion Science Cell Therapy or Stem Cell processing (>6 years experience)
• Minimum 2 years experience in TGA Good Manufacturing Practices (GMP) with a focus in QC assays and experience in qualification and or validation of cell and gene therapy assays

Desirable

• Postgraduate degree in Haematology Immunology Cell Therapy or Stem Cell Biology.

Staff Benefits

• Salary packaging & novated leasing throughMaxxia
• Flexible health insurance coverage throughHCF Health Insurance
• Onsite car & bike parking opportunities deducted pre-tax *subject to availability
• Fantastic onsite fitness facilities at The Alfred throughProSporthealth and fitness
• Childcare services at The Alfred managed byKU Childrens Services

If applicable please specify specific requirements that you require in your cover letter or CV.

For enquiries regarding this position please contact Wendy Fleming Head of Manufacturing - CAR-T -

Applications close 11pm AEDT Sunday 11th January 2025.

We embrace diversity and strive to have a workforce that reflects the communities we serve. We actively encourage applications from Aboriginal and Torres Strait Islander people people with disability and people of all genders sexualities and cultural backgrounds.

If you require adjustments to the recruitment and selection process or require an alternative format to any of the application materials please dont hesitate to get in touch with the contact person listed on this ad.

In accordance with the Health Services Amendment (Mandatory Vaccination of Healthcare Workers) Act 2020 health care workers in Category A or B roles (as determined by the departments risk ratings) are required to be vaccinated against influenza or hold an acceptable medical exemption.

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