Senior Scientist, Advanced Therapies - GMP Manufacturing

Western Sydney Local Health District; Sydney; Vor Ort; AUD 105.000 - 111.000; Vollzeit

Zusammenfassung

Western Sydney Local Health District at Westmead Hospital is seeking a Senior Hospital Scientist – Advanced Therapies to lead the translation of cellular therapies into validated GMP processes and treatments.

You will drive technology transfer, regulatory readiness and quality, collaborate with external investigators and partners, and help expand manufacturing capability within a licensed clinical manufacturing environment.

Qualifikationen

• Postgraduate degree in a relevant discipline such as cell biology, molecular biology, immunology, microbiology, or biochemistry.
• Demonstrated experience with manufacture, tech transfer or process development of cell-based products.
• Extensive experience handling blood and cellular therapy products including cell culture techniques.
• Working knowledge of analytical methods used in characterisation and release of cellular products, including flow cytometry.
• High-level understanding of regulatory requirements for cell therapy manufacture and experience with external audits.
• Demonstrated ability to work effectively with external parties including collaborators, sponsors or clients, and to scope technical work and deliver projects to agreed timelines.
• Excellent verbal and written communication and interpersonal skills demonstrated with all levels of employees.

Aufgaben

• Lead technology transfer and process validation: Assess incoming cellular therapy processes, identify gaps against GMP requirements, adapt manufacturing methods and establish critical process parameters and quality attributes.
• Drive regulatory readiness: Develop scientific and technical documentation for regulatory submissions, define product specifications and analytical release requirements, and support responses to regulatory agency questions.
• Deliver quality and compliance: Lead investigations into manufacturing deviations and out-of-specification results, conduct root cause analysis, and contribute to GMP manufacturing and facility readiness.
• Manage complex stakeholder projects: Act as the technical point of contact for partners and clients, coordinating deliverables, timelines and technical requirements across multiple projects.
• Build team and facility capability: Provide scientific guidance, training and day-to-day supervision of technical staff, contribute as Production Nominee for designated products, and support funding applications to expand manufacturing capacity.

Kenntnisse

GMP manufacturing

Tech transfer

Process development

Cell culture

Flow cytometry

Regulatory knowledge

External partnerships

Communication skills

Ausbildung

Postgraduate degree in cell biology, molecular biology, immunology, microbiology or biochemistry

Science degree in a relevant field

Jobbeschreibung

Western Sydney Local Health District at Westmead Hospital is seeking a Senior Hospital Scientist – Advanced Therapies to lead the translation of cellular therapies into validated GMP processes and treatments.

You will drive technology transfer, regulatory readiness and quality, collaborate with external investigators and partners, and help expand manufacturing capability within a licensed clinical manufacturing environment.