Director CMC Management Shanghai
A large pharmaceutical organisation in Shanghai in search for a Director to oversee CMC Management. The post holder must be well versed in Small Molecules. In this role you will be responsible for technology transfer, technical problem solving, process scale up and optimisation.
- Responsible for all CMC-related activities for Drug substance and Drug product small molecule drugs - Taking the molecule from early discovery to proof of concept, pilot scale, process scale up to commercial production.
- Synthetic route chemistry experience, route evaluation/selection, CDMO site selection, DS yield & COG improvements.
- Early pre-formulation characterisation, formulation, process scale up & optimisation.
- Develop process and control strategies for drug development, preclinical, clinical, and marketing processes
- Responsible for selection and management of Contract development and manufacturing operation (CDMO) and contract research organisation.
- Ensure delivery of robust scalable and cost-effective manufacturing routes of DS and DP to meet target product profile.
- Analytical : phase appropriate method development, method verification/transfer, and validation.
- Work closely with CRO, CMO, responsible for CMC-related content and provide technical support on a regular basis.
- Review analytical documents, stability results, manufacturing batch records and regulatory documents and approve as required.
- Responsible for writing CMC content for global regulatory documents - CDE, IND, IMPD and represent global agencies on CMC queries.
- Perform due diligence of new global opportunities/ platforms and assist in driving decision making.& selection.
- Interact with cross functional team to integrate CMC technical information and share to global teams as required.
Skills and Requirements
- D. or Master's degree in Pharmaceutical Chemistry or Organic Chemistry with deep understanding of small molecule synthetic chemistry, experience in formulation, process scale up and technology transfer of robust process.
- Preferably 10 -15 years of experience in drug substance and drug product process chemistry, taking product from POC to commercial : includes process chemistry, Analytical development, stability evaluation and drug manufacturing experience/technology transfer.
- Experience in small molecule drug development, pilot, large production transfer process, and related technical difficulties, familiar with analysis of drug quality standards and analytical methods to develop standards, at least responsible for 3 small molecule drug development and technology transfer process from POC to commercial.
- Attention to detail and ability to prioritise critical tasks and deliver in a timely and accurate manner.
- Innovative team player with high energy, proactive and strong sense of responsibility and integrity.
- Good bilingual communication and writing skills in both Chinese and English.
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