Your new company

Your new role

Based in Hong Kong and reporting to the Chief Executive Officer, responsible for all CMC-related activities

• Develop and lead all CMC-related activities (peptide and small molecule) including process chemistry, drug substance, drug product, analytical, and formulation, from the lead optimisation phase through to clinical development and commercialisation.
• Manage drug substance and drug product manufacturing service providers and API supply chains to support clinical trial development

• Author all CMC sections of regulatory filings including FDA, EMA and other national authorities to support the conduct of clinical trials
• Act as subject-matter expert for non-clinical CMC to both preclinical and clinical development teams, interact with all internal and external stakeholders to support CMC needs
• Ensure high-quality standards, develop SOPs, implement GMP compliance and QC/QA
• Monitor progress and regularly report to the CEO and other senior management, as needed
• Manage and monitor the CMC timelines and budget

What you'll need to succeed

• Master’s degree in a relevant discipline (e.g. Chemistry, Biochemistry, Biotechnology)
• 10+ years of relevant experience in the pharmaceutical/biotech industry
• Experience in the development of small molecules and/or peptides
• Wide breadth of knowledge in all aspects of CMC including process chemistry, drug substance, drug product, analytical, and formulation
• Hands-on experience of managing multiple internal and external stakeholders (e.g. working with CMOs on managing drug substance and drug product development)
• Experiences with writing CMC sections for regulatory filings and knowledge of current regulations in the US (particularly with the FDA) and EU
• Biotech/startup experience, comfortable working in a small and very dynamic team structure that partially acts remotely
• Proficient use of MS Office (Word, Excel, PowerPoint)
• Fluent communication in English, both written and spoken

What you need to do now

If you are interested in the above opportunity, please forward your latest resume to Kristi.pang@hays.com.hk or contact Kristi at +852 2230 7904 for more information.

If this role isn't quite right for you but you are looking to explore new opportunities in the life science sector, please contact Kristi Pang for a confidential discussion about your options.