Senior Scientist, Cell Therapy Method Development
- Malvern North, VIC USA
- Permanent
- Full-time
The Therapeutics Development & Supply - Analytical Development (TDS - AD) group is seeking an upbeat, highly motivated Senior Scientist to focus on potency analytical development for cell therapy products. The individual would work with team to develop functional potency strategies for lentivirus and CAR-T cells that will be endorsed by the health authorities. A successful candidate will have experience with the design, execution and optimization of a broad range of cell-based assays and will have the opportunity to engage in multi-functional teams. They will learn from and contribute to industry-leading drug discovery/development programs that have brought numerous quality therapeutics to patients and have made significant contributions to human health.You will be responsible for:
- Leading method development, validation, tech transfer, and lifecycle support activities for cell-based potency methods.
- Working collaboratively on a matrix environment, supporting and mentoring team members.
- Supporting regulatory filings, including INDs and BLAs.
- Representing the department on cross-functional and external teams and acting as a technical expert on potency.
- Communicating complex technical concepts to partners.
- Accurately capturing data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements.
- A minimum of a Bachelor's degree is required
- Advanced degree (Master's, PhD) is preferred.
- Ph.D. or equivalent advanced degree in Biochemistry, Virology, Biological Science, or a related field OR a Master's degree with 4+ years of experience in biopharmaceutical development OR a Bachelor’s degree with 6+ years of relevant experience is required.
- At least 4-6 years of relevant pharmaceutical, industry, or academic experience.
- Extensive experience in cell-based potency method development for viruses and cell therapies, including assay design and method robustness
- Extensive experience in potency strategies for cell therapies and regulatory recommendations
- Experience with method validation and method transfer to a QC environment; including in-depth knowledge of ICHQ14 and ICHQ2(R2)
- Must be detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data
- Strong written and verbal communication skills with the ability to convey complex scientific concepts clearly.
- Strong analytical problem solving, planning and organizational skills