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Director or above of Analytical Stability Center (Shanghai, China)

Key Accountibilities:

  • 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
  • Requirements:

  • 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