CMC AD -D

A new biopharmaceutical company is seeking to recruit a CMC AD-D to their office in Shanghai. The organisation rapidly develops innovative drugs to meet the needs of global patients, focusing on the global development of drugs for autoimmune diseases. With a fast-developing pipeline of drugs entering the clinical stage in the near future, this position is the perfect opportunity to work a dynamic up-and-coming organisation that prides itself on its highly recognisable clinical development capability.

Job Responsibilities:

• Manage and oversee the progress and quality of all clinical development programs.
• Selection of appropriate contract research/manufacturing organizations (CRO/CMO) for API supply, formulation development, analytical support, small and large-scale manufacture and packaging.
• Advice on content of technical agreements and contracts with CRO/CMOs. Advice on GLP/GMP/GCP compliance of CRO/CMOs.
• Management of API characterization, formulation development, analytical method development/validation, packaging development and process development at selected CRO/CMOs. Provision of regular project updates.
• Management of process scale-up and process validation at selected CMOs. Advice on commercial product supply chains.
• Ensuring that the CMO conducts the appropriate GMP batch release to support clinical trials and process validation procedures.

Skills and Requirements:

• Has a MS or Ph.D. in bio/chemistry, pharmacy, or related engineering subjects.
• 5 to 10 years of industry experience in pharma/biopharma setting
• Has at least 3-5 years of experience in CMC regulatory activities in supporting IND/CTA/NDA/MAA applications for small molecules.
• Served both multi-national pharmacos and local pharmacos with experience in tech-transfer and class 1.1 innovative drugs CTA/IND.
• Familiar with cFDA, ICH, and other relevant CMC/Quality and cGMP guidance documents.
• Should be familiar with CMC documentation in the CTD format.
• 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 Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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