Lead the efforts for analytical development studies within ARD department; function as project leader role in analytical development projects.
Plan and execute analytical method development and validation for drug substances/drug products; perform sample analyses including but not limited to samples for drug substances /drug products used for clinical trials;
Design and review method validation and stability program protocols for both drug substances and drug products where applicable; coordinate the execution of the protocols.
Plan, Coordinate, and oversee the work activities of scientific staff within the assigned group.
Design, Review and/or approve the formal analytical methods, method validation reports, stability study reports, Certificate of Analysis (CoA), summaries/reports related to analytical research and development works.
Be responsible for project management starting from project execution/project following up, regular analytical development update, review and approval of analytical protocols/reports and GMP documents. Assist the interaction with partners by issuing project reports, entertaining on-site visitation and through tele-, web- or video-conferencing etc.
Be expected to work closely with supervisor to meet project timelines, departmental goal, and customer requests. Be responsible for improving the operation efficiency and productivity while ensuring the current quality systems in full compliance to all applicable regulatory standards
Perform daily management of the analytical labs; conduct the group training in technology and compliance as needed.
Ph.D. degree in analytical chemistry, pharmaceutical analysis or other directly-related science discipline with experience or training in analytical chemistry, pharmaceutical analysis or equivalent experience.
Must have oversea study or working experience and industrial experience in Analytical R&D field is prefer.
Must be well familiar with the requirements of the FDA cGMP/GLP regulations, ICH guidelines and industry trend/practice in analytical development requirement
Must be able to coach junior scientists or managers to accomplish performance objectives.
Supervisory experience in a pharmaceutical R&D environment in both project and people management is desirable.
Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.