Principal Scientist, Drug Product Research & Development, China Full-time

Principal Scientist

The principal scientist will provide technical leadership and is responsible for scientific project management of the overall NME development strategy with the following scope of activities:

Oversee clinical formulation development activities in our strategic CRO.

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.

Drive the project advancement (pre-NME towards Ph II) in partnership with various functions and stakeholders such as discovery, API, Pharmaceutical Sciences, OSD, PLD, AD, CSC and CMC leaders while ensuring scientific standards are met and achieving a full understanding of drug product and process behavior.

Collaborate with external CROs and CMOs. Define development and business strategies for effective management of project deliverables. Ensure those project deliverables are achieved with appropriate balance of quality/time/cost and under compliance, e.g. GMP and GSP.

Qualifications:

• Ph.D. or at least Master degree in Pharmaceutics, Chemistry, Chemical Engineering, Pharmacy or a related field with 5+ years for Ph.D. or 10+ years for M.S. (senior scientist) or 10+ years for Ph.D. or 15+years for M.S. (principle scientist) of working experience
• Demonstrated competency and experience in drug product oral dosage form development within the pharmaceutical industry (oral solid in particular with various platforms)
• 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

Required Skills:

Preferred Skills:

Budget Management, Chemistry, Manufacturing, and Control (CMC), Clinical Trial Protocols, Critical Thinking, Cross-Functional Collaboration, Drug Discovery Development, Industry Analysis, Interdisciplinary Work, Market Research, Organizing, Pharmacokinetic Modeling, Process Improvements, Product Development, Product Strategies, Report Writing, Safety-Oriented, Scientific Research