Responsibilities
- Define and lead Angitia’s CMC development strategy from cell line selection through Phase II clinical supply of the pipeline.
- Establish clear technical standards for molecule development, formulation, analytical control strategies, and process scalability.
- Drive CMC planning for global regulatory submissions (INDs and IMPDs), including technical content for Module 3, comparability strategies, and direct support for regulatory inspections.
- Lead upstream and downstream process development, drug conjugation development, scale-up, and characterization to support early-stage programs.
- Oversee development, characterization, and banking of production cell lines to support robust, scalable manufacturing.
- Drive method development, qualification, validation, and analytical lifecycle management to support product quality and regulatory filings.
- Guide formulation design for IV and SubQ delivery, including high-concentration, device-compatible presentations.
- Build and lead a high-performing China based CMC development team.
- Collaborate closely with Regulatory, Quality, Supply Chain, Clinical, and Research to ensure technical alignment and execution across all programs.
- Serve as a core member of program governance and portfolio decision-making bodies.
- Own technical leadership across Drug Substance (DS), Drug Product (DP), Analytical Development, Cell Line Development, and device-enabled formulation development.
- Be accountable for the sending site activities during technology transfer to late stage (Phase III and BLA).
Work Arrangement
Remote (Country)
Team
Structure: Leads the China-based CMC team; serves as staff lead; collaborates with senior leaders in Clinical Development, CMC Operations, Project Management, Regulatory, Quality, Supply Chain, Clinical, and Research.. Reports to: CTO
Additional Information
- Strong bilingual (English and Chinese) efficiency ensuring seamless communications with global teams both internally and externally.
- The final job title will be commensurate with the candidate’s seniority, skills and level of experience.
- This role is China-based.
