Director or above of Analytical Stability Center (Shanghai, China)
The incumbent is to lead an Analytical R&D, Stability group (approx. 30 - 40 Scientists) in ASC to conduct all analytical and stability activities from early phase, late phase through to commercial phase support for API, drug product, and support of regulatory filing.
Lead the group to meet the preset goal/budget of department through streamlining/optimizing the workflow and maximizing the operation efficiency while maintaining full compliance
Develop/build a world class analytical & stability team including planning, recruiting/hiring, coaching/mentoring, and training for staffs and group leaders. Provide technical guidance/direction to subordinators as well as evaluate new analytical technologies to enhance department capabilities
Play a leading role in project management interaction with internal and external clients, formulation development, process development and quality assure units, etc.
Prepare, review and approve all analytical related documents, supervise project review meeting by TC or on-site visits to ensure projects meet the expected quality and within the desired timelines and budget
Able to handle regulatory inspections from FDA, EMA. CFDA etc and GMP audits and from clients as well as internal quality assurance unit
Assist senior management to expand business with existing customers and broad the customer basis by participating strategy development and business development activities with department head
Ph.D. degree in Analytical Chemistry or other directly related science discipline with pharmaceutical industry experience of 8 - 10 years in Analytical R&D/Quality Control within CMC/pharmaceutical development function; Oversee experience in US or Europe pharmaceutical companies and a minimum of 3-5 years of managerial experience desired
Excellent managerial skill in both people and projects being able to lead a large group of scientific staffs and a large portfolio of development and stability programs
Proven good track record of accomplishments in the Analytical R&D and CMC development area - managing different phases of new drug development program and launching new products in major global markets desirable.
li technical know-how to guide the team to maintain a leading industry role in analytical development as a contract research organization (CRO)
Must be familiar with requirements of FDA, EMA and CFDA regulations, ICH guidelines and GMP/GLP as well as drug product development process
Superb communication skills in written and verbal, and outstanding interpersonal skills are essential job requirements