Role: Cell Manufacturing Lead
Reporting to: VP(CMC) & Chief Scientific Officer
Job scope:
- Providing technical and strategic leadership for the Chemistry, Manufacturing, and Controls (CMC) of company’s clinical assets.
- Execute CMC strategy and submission plans to support regulatory filings for clinical trial applications in Singapore and US.
- Build and manage the cell manufacturing and quality control team in Singapore.
- In charge of the GMP cell manufacturing and process development in Singapore.
- Act as the Manufacturing Sciences and CMC expert during audits and interactions with regulatory agencies.
- Drive rigorous assessment of CMC issues, decisions to ensure the compliance with regulatory bodies’ requirement.
Requirement:
- Advanced degree in life sciences/pharmaceutical sciences/biomedical research; minimum MS, preferred PhD.
- Experience in CAR-T, TCR-T or other cell therapies.
- Familiar with immune cell manufacturing, flow cytometry analysis; Cytokine measurement assays; qPCR assays; etc.
- Self-motivated, good interpersonal skills.
- Project management experience. • Able to write/read Chinese will have an advantage.
