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Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Pharmaceutical Product R&D
Job Category:
Scientific/Technology
All Job Posting Locations:
Shanghai, China
Job Description:
This position is based in Shanghai, China and focuses on small molecule drug product development for oral products, particularly in early development phases (pre-NME towards Ph II).
This position will provide technical leadership and is responsible for scientific project management of the overall NME development strategy with the following scope of activities:
- Drive the project advancement (pre-NME towards Ph II) in partnership with various functions and stakeholders such as discovery, CPRD, PPDS, AD, CSC and CMC leaders while ensuring scientific standards are met and achieving a full understanding of drug product and process behavior.
- Develop & execute clinical formulation strategy and plan for compounds at early development phases, in line with the overall strategy and plan as outlined by the CMC team. The successful candidate will ensure alignment and endorsement of this strategy within the PPDS function.
- Define development and business strategies for effective management of project deliverables. Ensure those project deliverables, e.g. clinical formulation development and GMP production are achieved with appropriate balance of quality/time/cost and under compliance, e.g. GSP and GMP.
- Provide scientific guidance to scientists in CRO(s) when conducting polymorph screening, salt screening and solid form understanding and selection.
Qualifications
- PhD or at least Master degree in Pharmaceutics, Chemistry, Chemical Engineering, Pharmacy or a related field with 15+ years (Sr. Principle Scientist II) of working experience
- Sound knowledge and experience in pharmaceutical sciences, solid form (salt/polymorph) selection, preformulation and solid state characterization techniques
- Demonstrated competency and experience in drug product oral dosage form development within the pharmaceutical industry
- Good project management capabilities
- Demonstrated strategic thinking capabilities
- Strong interpersonal skills to effectively communicate with external sites and various internal and external functional areas
- Highly effective team member/player who can work in a matrix organization to accomplish assigned tasks
- Fluent English (both spoken and written) and good English scientific writing skills
- Chinese speaking is a must
- This position will be based in Shanghai, China and may require up to 15% international and domestic travel.
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