The Company and OpportunityViral 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 and only commercial manufacturing facility of its kind in Australia, uniquely integrated in the largest health, education, research, and innovation precinct in the country. Supported by a world-class clinical trial ecosystem, VVMF will in partnership design, develop and manufacture viral vector solutions for companies, customers and patients.VVMF is a new 'for-profit' biotech Contract Development and Manufacturing Organisation (CDMO) that will take over operation of the existing 'Stage 1' pilot facility within the Sydney Children's Health Network (SCHN) at Westmead and will commission and operate the 'Stage 2' commercial-scale manufacturing capability.Stage 1 is a pilot facility with a 25-litre capacity. Already operational, the pilot facility has successfully demonstrated capability in the manufacture of non-clinical grade viral vectors and created the opportunity to expand capability and capacity to be a commercially viable biotechnical manufacturing organisation. The facility is in the process of obtaining Good Manufacturing Practice (GMP) licence from the Therapeutic Goods Administration (TGA).Stage 2 development is well underway, having completed the design, secured statutory planning approval, selected manufacturing equipment and awarded a construction contract. Construction is due for completion end Q1 2025. The Stage 2 facility will have a 550-litre capacity and will further build capability while achieving financial sustainability by capturing the burgeoning national and international market for viral vectors. The commercial-scale facility will attract further skilled staff and supply a larger and more varied customer base.In preparation and lead up to facility completion, VVMF are looking for a Project Manager to join the team. This position will report to the Chief Operating Officer, and is a permanent, full-time position. This role is essential to ensure the success of VVMF's build from startup to fully operational CDMO.Key ResponsibilitiesPlanning and managing multiple projects and initiativesDefine, implement and manage project management standards, frameworks, and processesDevelop project plans, timelines, and budgets for key initiatives; monitor project progress and adjust as necessary to meet deliverablesServe as a liaison between leadership, project teams, and stakeholders, providing clear communication and regular project updatesIdentify potential risks and implement mitigation strategies to keep projects on trackIdentify opportunities for continuous improvement within the project lifecycle and manufacturing processesEnsure that projects adhere to all regulatory requirements (FDA, EMA, ICH, TGA) and quality standards, including GMPOversee project budgets, monitor expenses, and manage cost control; Report any variances and adjust plans as necessaryMaintain accurate, complete and organised project documentation to support audits, inspections, and regulatory submissionsOther tasks as requiredRequirementsHold a relevant degree in Project Management, Engineering, Pharmaceutical Sciences, or a related field. PMP or similar certification preferredDemonstrated experience in project management within pharmaceutical, biotech, or a regulated industryExperience in writing and execution of documentation, including SOPs, qualifications, validations, etc.Working knowledge and understanding of cGMPProficient in project management tools (MS Project, Smartsheet) and methodologies (Agile, Waterfall)Strong leadership and communication and interpersonal skillsAbility to prioritise and manage multiple tasks, and to facilitate and resolve cross-functional activities and issuesAlignment with VVMF valuesTo ApplyIf you meet the above criteria and are interested in this opportunity, please apply online in the first instance. Alternatively, you can contact Keelie Munroe on ****** or ring 0466 485 542 for a confidential discussion.An opportunity to join a pioneering facility at the forefront of biotechnical manufacturing.
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