Job Purpose

• Execution of the activities in CMC process development, cGMP clinical and commercial manufacturing, as well as regulatory filing preparation for IND & NDA submission.
• Assist in CMC department management, regarding quality, finance, inventory and documentation system.

Major Accountabilities

• Execute the CMC activities in CDMO upon the scheduled timeline. Troubleshooting for the technical problems in Process Development, Tech Transfer and GMP Manufacturing. Assist in technical documents review, including process development reports, analytical method, batch records, etc.
• Work closely with RA team to compile NDA/BLA dossier, including files authoring and review, supporting materials preparation, compliance inspection and data verification, etc. Technical Support for any queries from Health Authorities.
• Communicate and collaborate with Project Team Members from CMC, QA, Regulatory Affairs, Nonclinical/Clinical Development, Central PM, within CANbridge and with business partners. Identify and mitigate the Project Risks to achieve the milestones and goals.
• Work closely with Quality teams in compliance audits at CDMOs and Vendors; Assist in quality system build-up and improvement, including SOP drafting and revising, quality events tracking, etc.
• Responsible for CMC projects budget, contract, and payment management according to company policies.
• Responsible for CMC Inventory and Documents Management to ensure the Clinical Drug Supply and Good Documentation.

Competency Profile

• Ph.D./MS in life science, chemistry, biopharmaceutical or related.
• 3-5 years working experience in Biologics Process Development, GMP manufacturing or Quality desired. Level of position may be adjusted based on level of competency and years of experience.
• Good project management skills. Demonstrated ability to deliver outcomes while working on multiple projects simultaneously in a cross-functional team.
• Outstanding interpersonal and communication (written and verbal) skills both in English and Chinese is required.
• Highly organized, independent, self-motivated, problem-solving and team-worker.