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 are 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 that is 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;
- Lead a team of scientists to undertake manufacturing processes in accordance with Standard Operating Procedures established for vector production processes undertaken within the cleanroom facility.
- Provide training and validation for cleanroom manufacturing processes for gene therapy vectors.
- Lead manufacturing campaigns as required, with attention to meeting all applicable guidelines and standards for cleanroom use.
- Support activities of the facility and quality staff regarding the running of the cleanroom to required standards for vector production.
- Assist in the installation of 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.
- Act as process owner / SME for your designated area.
- Lead troubleshooting of critical cleanroom processes that encounter difficulties.
- Develop protocols for quality control and evaluation of manufacturing outcomes to required standards.
- Develop documentation of Standard Operating Procedures for gene therapy vector manufacture.
- Represent your designated area in audits by customers and regulators.
- Review completed batch documentation for accuracy and completeness.
- Responsible for ensuring compliance with regulatory requirements, work health and safety legislation/regulations, and industry standards in all supply chain and logistics processes.
- Proactively foster an open, supportive, values-based culture, and work environment.
- Lead and manage your team during production campaigns.
- Complete reports as required by VVMF, within in agreed time frames and to agreed standards.
- Write procedures and forms related to elements of the QMS that include but are not limited to change control, deviations, batch record and audit management.
- 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 VVMF meetings/events/activities as required.
- Maintain up to date and relevant knowledge of TGA, PIC/s and other local and foreign regulations and promote an organisation wide culture of audit -readiness.
- Other tasks as required.
It is essential to note that the Production Team Leader will conduct all manufacturing activities in accordance with VVMF SOPs and comply 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;
- Extensive aseptic technique experience in cell culture
- Previous experience in conducting training for new or established procedures/processes.
- Experience in writing and execution of documentation, including, but not limited to Standard Operating Procedures, Qualifications, Validations
- Demonstrated capacity to work as part of a team, and also work independently
- 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.
- Knowledge and understanding of current Good Manufacturing Practice (cGMP)
Desirable Experience;
- Experience working in a Lead Production Scientist position (or equivalent) within a biomanufacturing facility.
Personal Attributes
- Ability to engage with a variety of audiences, tailoring communication to suit the relevant audience.
- Excellent organisational skills.
- 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.
Qualifications Required:
- Science Degree or equivalent relevant experience in Pharmaceutical, biological or health sciences with extensive demonstrated GMP cleanroom experience.
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.
