- Founding team are global experts iPSC
- Young and international team
About Our Client
Our client is a biotech company focusing on iPSC cell therapy platform building and multiple universal cellular therapies. Its founding team has profound technical accumulation in iPSC, gene editing, stem cell differentiation and other cutting-edge fields and owns many independent intellectual property rights.
Page Executive is currently assigned to assist with VP CMC to support the progress of the pipeline
- The Vice President CMC will be responsible for all CMC activities in the company as well as all outsourced contract manufacturing of iPSC products in different stages of development ranging from GLP toxicology materials to Phase 1 to Phase 3 clinical trial material and commercial drug products.
- This role will provide leadership and support with cross-functional interactions across the entire R&D and G&A organization
- This includes extensive interactions with outsourced manufacturing, formulation and analytical teams, as well as project leadership responsible for the development of iPSC. The Vice President, CMC will report to the CEO of the company.
The Successful Applicant
- Advanced PhD degree in Biology, Chemistry or similar is preferred
- Hands on experience in supporting CMC process for drugs from pre-clinical to commercial is preferred.
- Knowledge of CDE and FDA CMC regulatory requirements
- For China based talents: background in cell therapy, gene therapy or other new modalities. For Overseas talents: hands-on experience in iPSC technology.
- Entrepreneurial mindset and ability to evaluate and take risks
- Strong leadership capability
- Fluent Mandarin and English skills
What's on Offer
- Successful candidate will report to CEO and work closely with the founding team.
- For experience Managers, Site Head role will be offered including supervision of Quality team, QC, QA and Regulatory.
- The package will include base pay, bonus scheme, stock option plan and additional allowances