Cell Production Operator/Assistant

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

We are seeking a Cell Production Operator/Assistant to support manufacture of the Company’s CAR-NK cells for clinical trials as part of the Manufacturing Development team. This position is full-time, initially a one year contract, with the potential for extension.

As a Cell Production Operator/Assistant, your day will be filled with diverse and critical tasks. Your role involves assisting the Manufacturing Development team and ensuring adherence to all standard operating procedures and Good Manufacturing Practices. Additionally, you will monitor environmental conditions in the cleanroom across multiple grades, support daily cleaning, support consumables restocking and maintain key lab equipment as requested.

Initially the role will be primarily located at the contract manufacturing site in Braeside and activities will be focused on establishing and operating Cartherics’ manufacturing process at the site.   Once the process has been successfully established, the position will be reviewed and, depending on acceptable performance and operational requirements, the Cell Production Operator / Assistant may be offered the opportunity to become part of the Company’s Clinical Manufacturing team or remain part of the Manufacturing Development team to work on scale-up and manufacturing process improvements.

With occasional weekend work, each day brings new challenges and integral contributions to the Company’s aim of rearming the immune system to fight cancer. This is a rare entry level opportunity to be involved in the production and delivery of cutting-edge therapies.

Duties

As a key member of the Manufacturing Development team your duties will include:

• Ensuring daily productivity, quality and safety goals are achieved and adhere to standard operating procedures and Good Manufacturing Practices.
• After receiving appropriate procedure-specific training, performing production and / or verification activities as directed.
• Developing proficiency in the CAR-NK manufacturing procedure.
• Performing calibration and maintenance activities related to process equipment (such as incubators, biosafety cabinets, etc.).
• Supporting stock management, including preparation of consumables and reagents for use in the manufacturing procedure.
• Supporting the writing of non-conformance reports, CAPAs and Change Control Plans, as required, as well as the writing of standard operating procedures, work instructions and batch records.
• Supporting facility daily cleaning and maintenance.
• Supporting and conducting environment monitoring in the facility in alignment with relevant standard operating procedures.
• Completing supporting facility paperwork, such as equipment logs, cleaning forms, etc., under QMS system.
• Working outside of normal work hours, including weekends, as required to meet experimental schedules (with compensatory time-off provided).
• Adhering to organisational policies and relevant laws in carrying out responsibilities.

Skills and Experience

The successful applicant will receive the appropriate training to allow for the safe and proficient execution of the CAR-NK manufacturing procedure.  To support this, the following skills and experience are considered essential for this role:

• A qualification (certificate or diploma or degree) in a life sciences discipline or equivalent industry experience
• Proficiency in aseptic cell culture techniques.
• High level of accuracy, technical capability and attention to detail.
• Demonstrated experience in accurate execution of standard operating procedures and recording of output, ideally in support of a highly complex research facility or production environment.
• A diligent and quality-driven approach to work.
• A clear and confident communicator.
• Ability to work within a fast-paced environment.
• Ability to multitask and work autonomously as well as in a team.
• Willingness to work within flexible schedules.

It would be desirable for the candidate to demonstrate the following:

• Experience in an ISO or regulated environment with Grade B/C cleanrooms.
• Experience in the calibration of equipment.
• Understanding of Quality Management Systems, including an understanding of the principles relating to standard operating procedures, work instructions and batch records and non-conformance reporting and CAPAs.

Benefits:

• Competitive salary, commensurate with experience.
• Comprehensive training and professional development opportunities.
• A collaborative and inclusive work environment that encourages innovation and personal growth.