锦鲤求职岗位描述
Shanghai, China | full time | Job ID: 11325
Position Summary:
The main responsibility of this role is to provide project overarching analytical support within the China organization and serve as a local interface for all clinical and commercial CMC project teams with Chinese collaboration partners, CDMOs, and vendors.
Specific tasks of this position include engaging directly with local collaboration partners, CDMOs, vendors, etc. to facilitate analytical transfers and supportquality control for mAb and ADC projects.
This role also involves supporting operational & troubleshooting activities on-site.
Your main responsibilities are:
On-site operational support at collaboration partners and CDMOs for AS&Tand quality control to support analytical transfers (ad-hoc site visits for troubleshooting etc.)
Review project documentation, including method development reports, analytical procedure protocols, method qualification/validation reports, according to regulatory guidelines
Independently drive assigned analytical packages within global technical operations
Ensure translation of technical documents for analytical transfer activities
Organization of technical visits at collaboration partners, CDMOs or vendors
Subject matter expert support for internal audits and Health Authority inspections
What you have to offer:
Master’s degree or preferably PhD in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field with at least 5 years of relevant professional experience in an international and highly regulated environment
Proven experience in protein and ADC analytical technologies (physico-chemical assays, functional assays, quality control); knowledge in small molecule analytics is considered a plus.
experience in analytical activities oflate-stage and commercial projects, including strategy definition and strategy execution, with a sound understanding of all stages in the drug development process.
Sound GMP knowledge and experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA)
Excellent project management skills, capable of working in cross-functional CMC teams and with external stakeholders
Excellent communication and negotiation skills as well as ability to communicate complex technical matters concisely to various stakeholders
Apply now - We look forward to receiving your application!
Apply to our Shanghai, China location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).
Job ID 11325 (please always specify if you have any questions)
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