Head of Pharmaceutical Development Service (ED Level)
This position, based in Shanghai, China, will report to PDS VP of WuXi AppTec, and be responsible for leading the Pre-formulation & formulation development Team within the PDS department; function in both, a business as well as a technical role.
- Contribute to growth of PDS business by using existing contacts and establishing contacts with new customers.
- Have independent business development responsibility for revenue targets for contribution to department revenues.
- Build new capabilities within the Pre-formulation/formulation group, by building up team and by evaluating new technologies/ equipment which can bring value to the customers
- Play a lead role during audits by customers and regulatory agencies by co-ordinating with Department head and Drug product QA Director
- Contribute to budgeting process of Pre-formulation/ formulation part and ability to operate within budget by maximizing efficiencies and pioneering innovative techniques
- Provide technical oversight (guidance) to Pre-formulation/formulation development staff and clinical trial product manufacturing staff in both development and manufacturing projects.
- Travel as required, to US and etc.
- MS or Ph.D. degree in Pharmaceutics or other directly-related science discipline with sufficient experience or training in formulation development as well as clinical product manufacturing.
- Demonstrated record of accomplishments in the formulation development of solid and liquid oral dosage forms intended for Phase I/II/III clinical trials. Must be able to work in a team-oriented manner in order to accomplish performance objectives.
- Must be proficient with the requirements of the FDA/ EMEA, cGMP regulations, ICH guidelines as well as drug development process.
- Experience in handling of formulation development for late stage dosage forms up to technical transfers is required.
- Good communication, open exchange of information and project teamwork will be required in order to meet job performance. There must be strong recognition of high performance standards and of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams.
- Strong communication skills
- People management
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