About The Company KE Select has partnered with Skin2Neuron (S2N), a privately held company pioneering therapeutic cell technologies for Alzheimer’s, Parkinson’s and Epilepsy. They have solid IP and a truly unique technology in autologous cell therapy that sets them apart from iPSC-based competition. S2N also has the support of a solid group of investors, including a top three global pharma company, and a clear path to the clinic.
They are in an exciting phase: tech transfer to a GMP CDMO partner ahead of “first in human” clinical trials, which is where you come in…
About the Role S2N seeks a highly skilled and enthusiastic Quality Manager to join their growing team based in Sydney and working in the cutting-edge field of cell therapy. The Quality Manager will play a key role in ensuring the continued development, implementation, and maintenance of a phase-appropriate quality system to support the late-stage development and contract manufacture of S2N’s cell-based therapies. Working closely with the Scientific, Regulatory and Clinical team, this individual will be responsible for overseeing quality operations, ensuring compliance with regulatory requirements, and promoting a “quality culture” across the organization.
Responsibilities:
- Manage the Quality Assurance (QA) function to support pre-clinical, clinical and commercial manufacturing of cell therapy products.
- Continue the development, implementation, and maintenance of S2N’s quality system in a phase-appropriate manner and in compliance with GMP and other applicable regulatory standards.
- Work with internal and external teams to manage the Quality aspects of tech transfer and subsequent QA processes.
- Collaborate with in-house and cross-functional teams including Process Development, Contract Manufacturing, QC, Regulatory Affairs, ensuring quality at every step.
- Manage and mentor our QA team members, promoting a quality-focused and collaborative work environment.
- Serve as the primary QA contact during regulatory interactions.
- Undertake audits of critical suppliers and service providers.
- Participate in the development, review and approval of SOPs, specifications, validation protocols, and quality-related documentation.
- Monitor quality metrics and lead quality review meetings to track performance and drive improvements.
About You: - Scientific qualifications in a relevant discipline (Biology, Biochemistry, Engineering); advanced degree preferred
- Experience leading the Quality function and management in a similar setting - cell therapies or biologics
- Experience with autologous or allogeneic cell therapy platforms will be highly regarded
- Strong working knowledge of GMP regulations, particularly as they relate to cell therapy products.
- Familiarity with electronic Quality Management Systems (eQMS)
- Experience with clinical and/or commercial manufacturing environments.
- Excellent organisational, leadership, and communication skills.
- Ability to thrive in a fast-paced, evolving startup environment.
- As it is likely our CDMO site will be interstate, the ability to undertake occasional interstate travel will be a requirement of this role.
Benefits: - Be part of a mission-driven team pioneering life-changing therapies.
- Collaborate with top talent in a highly innovative and dynamic environment.
- Competitive compensation, benefits, and opportunities for professional growth.
To Apply: If 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 keelie@keselect.com or ring 0466 485 542 for a confidential discussion.
KE Select is one of Australia's leading Life Science & Medical Technology recruitment firms. KE Select have established reach throughout ANZ, Asia and the UK and a market presence exceeding ten years. KE Select is quickly becoming the recruiter of choice for many organisations within the Pathology, Life Science, Pharmaceutical, Medical Device and Clinical space.
