（高级）分析研究员，小分子CMC（博士岗）

General Description:

This position is a scientific role, which provides scientific research and project management support for ARD

Essential Functions of the job:

• Select appropriate methods and techniques and perform phase appropriate analytical method development and validation to support drug substance and drug product development
• Recommend alternatives, research new methods/techniques, and independently develop solutions to problems
• Design and oversee execution of stability studies, summarize data and justify specifications, design analytical strategies
• Independently author technical reports, protocols
• Participate in the authoring of CMC sections of the clinical trial applications (IND/IMPD/CTA) and marketing applications (NDA/MAA) with manager’s guidance
• Work as analytical workstream lead (WSL) or acting analytical team lead (acting ATL) for one or more projects under the supervision of analytical team lead (ATL), and collaborate with cross functional CMC team to deliver overall project goal
• May work as ATL with manager supervision
• Support platform establishment as needed by providing scientific input and workflow design
• Publish and/or present in conferences with manager’s supervision, build scientific connections in the analytical science community

Education Required:

Ph.D. in pharmaceutical science, chemistry, biology, engineering or other relevant subjects with industry experience, relevant postdoc experience may be considered as industry experience

Computer Skills: MS Office and other relevant scientific software

Other Qualifications:

• Demonstrate technical expertise and scientific understanding on state-of-the-art analytical technologies (e.g.: chromatography, mass spectrometry, solid state characterization) and act as a subject matter expert for the CMC team
• Good track record of publication and/or conference presentation
• Excellent learning agility, strong passion for science
• Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have good organizational and planning skills
• Good scientific and business communication skills (both verbal and technical) and interpersonal skills
• Capable of using English as working language (both in verbal and in writing)