职位描述
Essential Duties and Responsibilities:
1. Lead a team of chemists to bridge between Discovery Chemistry and Process Chemistry: Optimize discovery route for fast, non-GLP/GLP/GMP deliveries.
2. Work with project teams to identify API requirements, manage and optimize aggressive project timelines, work closely with CMC functions .
3. Source and develop raw materials, intermediates, and regulatory starting materials.
4. Identify, select, and manage CROs and CDMOs.
5. Author/review the relevant CMC sections of regulatory filings and patent applications.
6. Partner with analytical development and formulation development to design overall CMC strategy for programs.
7. Communicate effectively within cross-functional project teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Project Management, Legal and Regulatory.
Education and/or Work Experience Requirements:
•Master or PhD degree in Life Sciences, Chemistry, Pharmacy, or related field.
•Minimum20 years of experience in the small molecule area of the pharmaceutical industry.
•Extensive knowledge of all aspects of chemical-pharmaceutical CMC is preferred.
•Experience with process development, manufacturing, IND and NDA filings and familiarity with relevant NMPA, FDA, and EMA regulations.
•Fluent in written and verbal English.
•Strong project management and time management skills.
•Excellent interpersonal and communication skills with the ability to build strong rapport with all levels of the organization.
•Experience in communicating with international teams is a plus.
•Familiar with Microsoft Office