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Careers

Production Operator – Cellular Therapies

Cell Therapies Pty Ltd (CTPL) is a company that focusses on cellular and gene therapy products – a cutting-edge field that provides the newest treatments for diseases that have no suitable therapy, such as cancer and rare diseases.  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 (CTPL was established in 2003), 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 who desperately need them.

We are seeking motivated cleanroom Production Operators to join our team.  As a Production Operator, you will be tasked to perform critical aseptic manufacturing processes for clinical and commercial cellular therapy products.  These products must comply with the Australian Code of Good Manufacturing Practice (GMP) for human blood and blood components, human tissues and human cellular therapy products.

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.  Come join our team!

Key activities for this role include:

  • Aseptically manipulating and processing human cells, tissues and blood components in a cleanroom environment in compliance with QA processes and procedures to produce GMP compliant therapeutic products.
  • Gowning for, working within and cleaning classified cleanroom facilities.
  • Set up manufacturing kits and equipment for manufacturing processes.
  • Adhering to standard operating procedures and Good Manufacturing Practice (GMP).
  • Completing batch records and other facility documentation according to GMP and Quality Assurance requirements.
  • Performing environmental monitoring, calibration and maintenance activities related to process equipment.
  • Participating in manufacturing process improvement activities.
  • Routine overtime and some weekend work will be required.
  • Use of a variety of computer based applications.

The ideal candidate has the following skills/experience:

  • A degree in a life sciences discipline or equivalent industry experience.
  • Experience working within a cleanroom environment and working in biosafety cabinets.
  • Experience working in cell culture including aseptic media preparation, culture inoculation and harvests, performance of cell viability and cell counts, use of microscopes, performing calculations, pipetting, performing dilutions and aliquoting.
  • Experience working in a GMP environment such as the manufacture of sterile or aseptic goods (injectable pharmaceuticals or commercial compounding pharmacy), or highly controlled process environments handling human tissue (such as pathology laboratories).
  • Experience with large scale cell culture equipment such as cell savers, bioreactors, filtration systems would be advantageous.
  • High level of accuracy, technical capability and attention to detail.
  • A diligent and quality-driven approach.
  • A clear and confident communicator.
  • Ability to multitask and work autonomously as well as in teams.
  • Comfortable working within a hospital environment.

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.

Applications, including a CV and covering letter addressing the key requirements of the role, should be submitted via Seek

Please note that only applications received through this link will be considered. The selection process will include a practical skills assessment task.

To view the position description please click here Production Operator Position Description

 

Quality Control Analyst – Cellular Therapies

Cell Therapies Pty Ltd (CTPL) is a company that focusses on cellular and gene therapy products – a cutting-edge field that provides the newest treatments for diseases that have no suitable therapy, such as cancer and rare diseases.  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 (CTPL was established in 2003), 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 who desperately need them.

We are seeking a motivated Quality Control Analyst to join our team.  As a Quality Control Analyst, you will be tasked to perform critical analytical testing and method development for clinical and commercial cellular therapy products.  These products must comply with the Australian Code of Good Manufacturing Practice (GMP) for human blood and blood components, human tissues and human cellular therapy products. Although the ideal candidate will have previous GMP experience, candidates with pathology or research backgrounds with the applicable technical skills are encouraged to apply.

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 expand your experience within the cell therapy industry and be directly involved in the newest advanced therapies that can make a serious impact on patient’s lives.  Come join our team!

Key activities for this role include:

  • Quality control testing associated with the manufacture of human cell therapeutics to produce GMP compliant therapeutic products
  • Lead/participate in technical transfer of a variety of analytical test method technologies associated with cell therapy products
  • Develop, troubleshoot and modify transferred test methods and qualify/validate methods to meet GMP and applicable regulatory requirements
  • Writing and execution of experimental protocols and reports
  • Client liaison for project QC related items as required
  • Routine overtime and some weekend work will be required

The ideal candidate has the following skills/experience:

Essential:

  • Experience in quality control and method development associated with both fresh and cryopreserved cell therapy products, including flow cytometry, ELISA, light microscopy, safety testing, cell counting and other cell based assays
  • BAppSc or BSc in life sciences or equivalent industry experience
  • Complex data analysis and report writing skills
  • Demonstrated research and analytical skills including the use of a variety of data sources to provide advice and recommendation to senior staff and clients
  • Understanding of maintenance and commissioning of equipment and a mechanical aptitude

Desirable:

  • Specific experience in working within cGMP (Human Blood and Tissue) compliant service
  • Experience in DNA analysis, PCR, protein analysis, molecular diagnostics
  • Experience in cell culture under aseptic conditions
  • Understanding of medical microbiology

The Salary offered will be commensurate with skills, experience and industry standards.  GMP training will be provided as part of the induction process.

Applications, including a CV and covering letter addressing the key requirements of the role, should be submitted via Seek

Please note that only applications received through this link will be considered. The selection process will include a practical skills assessment task.

To view the position description please click here QC Analyst Position Description

 

Document Controller – Cellular Therapies

Cell Therapies Pty Ltd (CTPL) is a company that focusses on cellular and gene therapy products – a cutting-edge field that provides the newest treatments for diseases that have no suitable therapy, such as cancer and rare diseases.  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 (CTPL was established in 2003), 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 who desperately need them.

We are seeking a motivated Document Controller to join our team.  As a Document Controller, you will be tasked to administer and be accountable for the documentation system for clinical and commercial cellular therapy products.  These products must comply with the Australian Code of Good Manufacturing Practice (GMP) for human blood and blood components, human tissues and human cellular therapy products.

This is a full-time position initially for 12 months 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 expand your experience within the cell therapy industry and be directly involved in the newest advanced therapies that can make a serious impact on patient’s lives.  Come join our team!

Key activities for this role include:

  • All batch records are controlled and issued on time to meet manufacturing timelines
  • Documents are formatted correctly and have appropriate signatures prior to approval in the electronic documentation system QPulse
  • Documents are archived and retrieved as per SOP and client requirements
  • Developing, drafting, updating and authoring SOPs in relation to the documentation system
  • Scanning of completed records and sending to external clients
  • Participation in the maintenance of cGMP compliant quality systems as audited by the Therapeutics Goods Administration
  • Effective and professional communication with other CT staff and external clients

The ideal candidate has the following skills/experience:

Essential:

  • Advanced Microsoft word certification and practical experience
  • Ability to follow procedures and defined work flows
  • Demonstrated ability to work and communicate cooperatively with multiple teams and competing demands
  • Excellent attention to detail
  • Responsible attitude and work ethic

Desirable:

  • Specific experience in document control in a cGMP compliant service
  • Experience with QPulse electronic quality management system
  • Previous experience in a Quality Assurance role
  • Advanced Microsoft suite experience

The Salary offered will be commensurate with skills, experience and industry standards, this role can accommodate flexible working arrangements. GMP training will be provided as part of the induction process.

Applications, including a CV and covering letter addressing the key requirements of the role, should be submitted via Seek

To view the position description please click here Document Controller Position Description

 

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