GMP Production Officer
The Malaghan Institute is New Zealand’s leading independent health research organisation, with around 90 staff dedicated to finding cures for diseases using the body’s own immune system.
We are seeking two individuals to join our CAR-T Cancer Immunotherapy clinical trial as Production Officers. Ideally you will have experience in a broad range of cell biology studies and techniques. This position will be an initial two-year fixed term contract. Training will be provided in production, quality control and regulatory compliance following the requirements of work under Good Manufacturing Practice (GMP) in a strict regulatory environment (US/EU/UK/ANZ).
Responsibilities will include:
- Production, QC analysis and monitoring for the release of CAR-T cell cancer immunotherapy products according to GMP standards .
- Preparation and submission of documents required for the regulatory permissions for the start of clinical trials.
- Immunological analysis of samples obtained from patients enrolled in the outlined clinical trials.
- Maintain up to date records of experimental procedures in line with the requirements of clinical Good Laboratory Practice (GLP).
The successful candidates may have experience as a Research Assistant, Research Officer or similar in a cell culture or cellular immunology environment.
The following skills are desirable for this position:
- A degree in Biomedical Science or related discipline
- Knowledge of cellular immunology
- Ability to design and perform scientific experiments and to collect, record and interpret experimental data
- Experience in handling of primary and established cell lines (1 year+)
- Experience in developing standard operating procedures
Experience of the one or more of the following would be a significant advantage:
- Master’s degree or equivalent by virtue of research based experience
- Experience in FACS based analysis of immunological responses
- Knowledge of the regulatory requirements for work in compliance with cGMP and/or cGLP regulations
- Knowledge of: Tumour immunology, Molecular virology, including retro/lentivirus vector design, and/or development
- Analysis of pattern recognition, stimulation, co-stimulation, and inhibitory pathways involved in immune regulation
- Clinical trials/Translational medicine
What we offer in return:
- Annual salary of $45,000 – $60,000 (depending on experience) per annum, with annual pay reviews.
- Negotiable relocation and Immigration support if required.
- Supportive environment within great facility in Wellington, New Zealand.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, or disability status.