Director of Pharmaceutical Development
at Shenzhen HighTide Biopharmaceutical, Ltd. in Shenzhen Guangdong China
Shenzhen HighTide Biopharmaceutical is a joint venture formed between a team of oversea returnees and Shenzhen Hepalink, the world largest heparin API supplier in 2011. The company is focused on the development of peptide therapeutics for unmet medical needs, such as diabetes, diabetic complications, and cancers.
The candidate will oversea the pharmaceutical development of company’s peptide drug leads. In particular, the candidate will be responsible for leading the development and execution of all parts of the CMC development to support the IND filing that satisfy both CFDA and FDA requirement.
- Lead the pharmaceutical development team; oversea and coordinate the pharmaceutical development projects
- Lead all CMC activities, including but not limit to planning and coordinating the drug substance and drug product development to assure timely development, registration and commercialization of investigational therapeutics
- Lead the team to operation the tech-transfer of CMC and relative studies, prepare the documentations of CMC for the application of IND and NDA.
- Communicate with CROs and CMOs for the CMC studies for the technical issues
- Report directly to CEO
- In-depth knowledge of the drug development process with CFDA/FDA. Proven track records in pharmaceutical development in a biotech, pharmaceutical or CMO company.
- Pharmaceutical development experience in peptide therapeutics will be given preferred considerations.
- Solid knowledge of regulatory guidelines of CFDA, FDA, and ICH for CMC studies
- Strong planning and tracking skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management.
- Excellent interpersonal and public speaking skills and strong ability to work in a start-up environment.
- Willingness to travel domestically and internationally.
HR Manager, Shenzhen HighTide Biopharmaceutical, Ltd.
Email: email@example.com; Phone: +86 755 2153 4843
We offer competitive salary and fringe benefits that are commensurate with qualifications.