About the Company
Cartherics (cartherics.com) is a private, early-stage, cellular immunotherapy company, with a core focus on the development of CAR-NK, CAR-T and other immune cell therapies for the treatment of cancer. It aims to be a world leader in the development of “off-the-shelf” CAR-cell products. It employs ~20 full-time scientists, complemented by support staff, part-time employees, and a pool of experienced advisors and consultants. The Company’s head office and research activities are based at its purpose-built facility in Notting Hill. Manufacturing operations are based at a contract manufacturing facility in Braeside.
About the Role
This is a hybrid manufacturing / process development role, combining responsibilities as a Production Operator within a Good Manufacturing Practice (GMP) contract manufacturing facility and as a Research Scientist in the Company’s PC2 laboratory. The successful candidate will initially play a key role in the production of clinical trial material in a GMP environment, then move into manufacturing process improvement as part of ongoing research and development activities. This role provides an excellent opportunity to gain hands-on experience with advanced manufacturing technologies and innovative research methods.
Duties
The successful candidate will work as part of the Manufacturing Development Team and will be required to:
Perform GMP manufacturing operations:
- After receiving appropriate training on manufacturing-related protocols, the individual is expected to perform production roles independently.
- Individual is expected to continuously develop proficiency in the manufacturing procedure.
Support facility operations and equipment maintenance:
- Assist in routine cleaning and maintenance of the equipment in the GMP facility and PC2 laboratory.
Conduct manufacturing process improvement and up-scaling:
- Scientific and technical contributions to manufacturing method development and up-scaling.
- Perform laboratory tasks related to cell biology, molecular biology, and other relevant research areas.
- Analyse and communicate experimental results effectively, contributing to team discussions and strategy meetings.
Undertake data management and record keeping in alignment with Company’s Quality Management System:
- Support the writing of standard operating procedures, working instructions, and batch records.
- Maintain accurate and complete records of all production and research activities.
- Manage data entry and documentation within relevant databases to ensure traceability and regulatory compliance.
Support team collaboration and communication:
- Foster a collaborative environment by sharing knowledge and supporting the wider team objectives.
- Remain flexible and adaptable to adjust personal duties and objectives in alignment with the team’s goals and the company’s overall strategies.
- Work outside of normal work hours, including weekends, as required to meet experimental schedules (with compensatory time-off provided).
Adhere to organisational policies and safety standards:
- Follow all Company policies and procedures, with a focus on regulatory compliance, safety, and productivity.
- Adhere to standard operating procedures and good manufacturing practices and ensure a safe working environment.
Skills and Experience
Candidates for the position should possess:
- A BSc/BBiomedSc with Honours, ideally a PhD, with experience in immunology, molecular biology, and/or cell biology.
- Proficiency in aseptic cell culture techniques with detailed understanding of maintenance and sterility requirements in tissue culture laboratories.
- Experience working within accredited Quality Management Systems and familiarity with standard operating procedures, working instructions, and batch records.
- Experience with human-induced pluripotent stem cells (iPSCs) cell culture and hematopoietic stem cell lineage differentiation is preferred but not essential.
- Ability to thrive in a fast-paced production environment managing multiple tasks and duties effectively.
- Well-organised, with an ability to work independently.
- Experience with retaining appropriate experimental records and data management (including analysis and reporting).
- Strong communication skills to effectively convey plans, data, and work within the team.
- Willingness to work flexible schedules to meet business requirements.
- Willingness and aptitude to work within a GMP environment.
Preference will be given to candidates with:
- Experience in up-scale manufacturing or cell production in the cell therapeutic field.
- Previous experience in working in clean rooms and/or GMP facilities.
- Experience in multi-parameter flow cytometry, cell cryopreservation, ELISA and cell biology-based functional assays.
Benefits:
- Competitive salary, commensurate with experience.
- Comprehensive training and professional development opportunities.
- A collaborative and inclusive work environment that encourages innovation and personal growth.