·The primary responsibilities involve leading and overseeing all aspects of drug product formulation development of small molecules project for both clinical use and commercial, providing leadership to ensure drug product supply for clinical studies, and supporting CMC dossier preparation and regulatory submissions, from IND to NDA.

·Work with external CROs and CMOs to ensure timely execution of high-quality deliverables of formulation and process development , both for early clinical stage (IND filing, phase I) and later clinical stage (phase II/III, NDA filing,).

·Support seamless filing of DP section of CMC Dossiers for assigned projects, registration and approval, emphasizing scientific content and quality consistent with current & evolving regulatory requirements and expectations of NMPA/FDA/EMA. The responsibility may also include CMC aspects of dossiers for life cycle management.

·Participates in CMC project teams, work with internal cross functional teams as well as local and foreign partners/consultants to ensure project objectives are achieved.

·Builds and strengthens relationships with local and global partners.

·Proactively alerts Leadership Team regarding CMC problems with regards to drug product and dossier content before they become issues.

·Ensures drug products delivered on time without CMC issues that would otherwise slow down clinical progress.

·Master/PhD degree with background in chemistry, pharmaceutical development. Preferred with training and experience in formulation development of small molecules innovative drug.

·5-10 years of pharmaceutical R&D development experience within pharmaceutical /biotech industry, oncology drug development is plus. Development experience of NDA and oral solid dosage forms is preferred.

·Knowledge and/or experience in CMC dossiers, regulatory CMC and operations and compliance.

·Fluent in both oral and written English (mandatory) and Chinese.

Contact Person：Frank Wang

Mobile：15680922101

Mail：frank.wang@isaac-kenneth.com