About VVMF Viral Vector Manufacturing Facility (VVMF) has exclusively partnered with KE Select Scientific & Medical Recruitment Specialists to support their recruitment strategy and growth.
VVMF is the first commercial manufacturing facility of its kind in Australia. Based at the Westmead Health Precinct in Westmead, NSW, VVMF is uniquely integrated in the largest health, education, research, and innovation precinct in the country. VVMF is set to become a leading Contract Development and Manufacturing Organisation (CDMO) in Asia-Pacific, producing clinical and commercial-grade viral vectors for advanced therapeutic applications.
VVMF is building a values-based organisation committed to equality, diversity, and inclusion. They aim to deliver an outstanding product and are committed to excellence in service and experience for everyone associated with their facility.
The Opportunity The opportunity exists for an experienced Production Scientist to join the VVMF facility.
Reporting directly to the Production Manager, you will be responsible for the manufacture of gene therapy vectors for clinical use in humans.
Key Responsibilities:
With the support and guidance from the Production Team Lead, the Production scientist will be responsible for the following duties;
- Undertake manufacturing processes in accordance with Standard Operating Procedures established for vector production processes undertaken within the cleanroom facility.
- Manage own training plan and undergo training and validation for cleanroom manufacturing processes for gene therapy vectors.
- Once trained, participate in manufacturing campaigns as required, with attention to meeting all applicable guidelines and standards for cleanroom use.
- Support the facility and quality staff's activities regarding the running of the cleanroom to the required standards for vector production.
- Assist in installing vector production equipment to required standards, including documentation of IQ, OQ, PQ and PV processes.
- Undertake validation studies for equipment and processes as required.
- Provide support for the maintenance and calibration of vector production-specific equipment.
- Assist in troubleshooting critical cleanroom processes that encounter difficulties.
- Assist in the development of protocols for quality control and evaluation of manufacturing outcomes to required standards.
- Assist in developing and documenting Standard Operating Procedures for gene therapy vector manufacture.
- Complete reports as required by VVMF within the agreed time frames and to agreed standards.
- Identify continuous improvement opportunities and implement solutions to improve programs and meet business goals.
- Carry out and manage projects as requested, ensuring project requirements are met within agreed time frames and delivered to agreed standards.
- Participating in VVMFF meetings/events/activities as required..
- Any other required tasks.
It is essential to note that the Production Scientist will conduct all manufacturing activities in accordance with VVMF SOP’s and compliant with all TGA, FDA and/or EMA regulatory requirements.
This role will be required to support the Operations team as necessary with additional tasks outside of day-to-day production
About You Experience Required;
- Experience within a GMP manufacturing environment is essential.
- Hands-on knowledge and understanding of current Good Manufacturing Practices (cGMP).
- Practical laboratory experience in aseptic procedures and/or tissue culture.
- Demonstrated capacity to work as part of a team, and also work independently while strictly following Standard Operating Procedures and adhering to quality system guidelines and standards.
- Experience in documentation of science based, technical protocols and processes.
- Demonstrated effective, collaborative and professional communication skills, time management skills and timely delivery of required deliverables.
Desirable Experience;
- Experience working in a Production Scientist position (or equivalent) within a biomanufacturing facility.
Personal Attributes
- Strong interpersonal and communication skills (written, oral and virtual).
- Ability to prioritise and manage multiple tasks and to facilitate and resolve cross-functional activities and issues.
- A high level of professionalism.
- Positive, “can do” attitude.
- Strong problem-solving skills, which are solutions-focused.
- Innovative, adaptable, and resilient.
- Proven team player who takes own initiative in supporting and achieving team goals/objectives.
- Strong attention to detail and highly organised.
- Personal alignment with VVMF values.
- Maintain a current and satisfactory National Police Check.
- Maintain eligibility to work in Australia.
Production runs are delivered during and outside of a usual business day. The ability and willingness to work as required to meet your role and production requirements is essential; this includes early starts, afternoons, evenings, and weekends
To be considered for this current opportunity, or any other opportunities within the Viral Vector Manufacturing Facility (VVMF) VVMF, please send your CV to our regularly attended dedicated VVMF careers inbox: vvmfcareers@keselect.com. Due to demand, only suitable applicants will be contacted.
