The key focus of this role is oral-drug product process development and optimization, scale-up, tech transfer & validation, and clinical supplies manufacturing activities at CMOs to support on-going clinical trials as well as commercial for our small molecule portfolio.
Key Responsibilities include:
- Oversee drug product manufacturing activities at CMOs to ensure cGMP compliance, drug products meeting all quality standards, and timely delivery of clinical supplies from Phase 1 through commercial launch.
- Understand QbD concepts, apply effective DoE approaches to generate and execute process development/optimization plans, enable deep understanding of the manufacturing processes and possible impacts on drug product critical quality attributes.
- Review, summarize and interpret process development data generated by CMOs, conduct statistical design and analysis, identify critical material attribu