CMC - Purification
A leading biopharmaceutical company is seeking to recruit a CMC - Purification to their office in Shanghai. The organisation is devoted to the development of a new generation of innovative drugs and prides itself on its broad immune-oncology pipeline. This is an exciting opportunity to join a leading organisation.
- Assist in the promotion of biomacromolecules projects, work closely with CRO/CMO, and participate in relevant project management.
- Participate in different stages of process development of macromolecular projects and provide technical support, including initial process establishment, optimisation, scale-up, process change, process validation, technology transfer, etc.
- Involved in reviewing of all CMO documents from protocols to records and reports, to ensure the scientific logic, integrity, traceability of content.
- Work with Regulatory Affairs to ensure the timely delivery of CMC submission documents.
- Complete other related tasks assigned by the superior.
Skills and Requirements:
- Bachelor degree or above, with at least 3 years working experience in pharmaceutical industry.
- Familiar with CFDA, FDA drug development, registration and other regulatory documents, and ICH guidelines.
- Proficient in at least one of function such as upstream, downstream or formulation in the development and manufacture of macromolecular drugs; familiar with the whole link is preferred. Summarize project progress and technical data of the CMC department.
- Anticipate/identify problems and takes appropriate action to correct.
- Good organisation, coordination and communication skills.
- Fluent English (oral and writing) is preferred.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Lily Zhao at +86 21 51694106 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.