Our client, an Immunotherapy Biotech firm, is looking for a CMC Subject Matter Expert (SME) to be part of their leadership team in Singapore. You will manage the setup of local cell manufacturing process and building of team, ensure compliance to guidelines by regulatory bodies, be the Corporate Representative for audit, as well as clinical affairs related matters (covering Singapore and US for clinical trials application).
The successful candidate will hold a relevant MS/PhD in medical science disciplines, seasoned project manager well-versed in CAR-T / TCT-T / other cell therapies, as well as cell manufacturing (immune cell) and bioassays. You will have excellent stakeholder management skills with proven leadership in developing team.
This role requires Chinese and English language skills with FDA experience. Candidate will be offered competitive salary (benchmark to U.S. norm), plus relocation package. They plan to build U.S. operations and teams later when you would have the opportunity and choice of moving back.