Responsibilities:

Direct team on analytical activities to support medicinal chemistry and preclinical development.

•Provide analytical and structural characterization data on newly synthesized compounds;

•Direct analytical team on the studies of the physicochemical properties and other pre-formulation assessments of selected compounds.

•Provide analytical support on preclinical tox studies.

Develop control strategies and methodologies for drug substances and drug products under a GxP environment.

•Ensure analytical activities are conducted in compliant with applicable GxP and EHS requirements.

•Ensure analytical data and related CMC documents fully meet data integrity requirements.

•Direct and lead analytical team to deliver all the project related milestones on time as agreed upon with global project teams.

•Direct analytical team on developing and validating analytical test methods.

•Establish and set-up specifications for drug substances and drug products with justifications.

•Lead on stability study strategies, to support the retest dating of clinical supplies and final NDA filing in global markets.

•Author/review/approve experimental protocols, validation reports, test methods and technical memos/reports.

•Guide team to analyze data, evaluate results, and form conclusions.

•Ensure timely, accurate and compliant documentation.

Provide decisive leadership and operational expertise

•Work cross-functionally within the organization to help shape and meet product life-cycle timelines and support synthesis and formulation divisions.

•Ensure successful tech transfer between internal organizations and between ARD and TPL/CMO.

•Establishes and maintain an environment that assures the recruitment and retention of top talents, continued staff development and the recognition of high potential technical and managerial talents within areas of responsibility.

Demonstrate high proficiency across a wide range of relevant technologies. Maintain a high level of productivity in the lab and/or pilot plant

•Formulates conclusions and designs follow-on experiments based on multidisciplinary data.

•Ensures that high quality products are developed by applying strong scientific rationale, cutting-edge technologies, Quality by Design (QbD) principles, and statistical approaches.

Qualifications:

•PhD degree in Chemistry or other closely related disciplines with 5+ years relevant work experience in pharmaceutical industry or Master degree with 10+ years of experience. Experience in major US or European pharmaceutical companies is an added advantage.

•Hands-on experience on analytical team building with strong problem-solving skills.

•Conversant with ICH guidelines, applicable law and regulations of major markets (China, US, EU, Japan, etc.), and other compendial requirements (USP, EP, ChP etc.)

•Experienced in CMC document preparation for IND and NDA filing.

•The candidate should be a very effective communicator, interacting with key stakeholders, regulators and other technical lines and matrix teams.

•Strong written and communication skills and an ability to work effectively with a diverse team of co-workers in a dynamic environment.

•Possess thorough theoretical understanding of own scientific discipline.