CMC API
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A leading pharmaceutical company that accelerates the launch and listing of drugs across China is seeking a CMC API to join their office in Shanghai. The organisation, which is a subsidiary of an international pharmaceutical corporation, specialises in increasing China's core competitive power in the innovation of new drugs. This is an exciting opportunity to work with a prestigious company that develops first-class drugs.
Job Responsibilities:
- Managing and overseeing API process R&D and production activities for projects at CRO/CMO to ensure well resource/equipment planning and on-time delivery (100%).
- Performing synthetic route design and scouting with innovative inputs for API process R&D purpose.
- Supporting/visiting at CMO production site.
- Performing OOT, OOS, deviation investigation, and troubleshooting in a timely manner.
- Participating in process/product life-cycle know-how management, like preparing Technical packages.
- Participating in CMOs management by monitoring their performance and developing their capability.
- Identifying, evaluating, and developing CMOs/suppliers for supporting API process R&D and production activities.
Skills and Requirements:
- D. qualified with at least 3 years of working experience in the area of API process R&D and production.
- Experience working as a leading chemist in API projects.
- Demonstrable technical expertise in API process R&D and production.
- Experience with running scale-up projects in chemical (pilot) plant.
- Knowledge of cGMP and experience in late phase API projects.
- Solid knowledge and understanding of organic synthesis.
- Good knowledge and understanding of chemical/pharmaceutical process up-scaling and (pilot) production.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
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.
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