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Senior Director and above – Analytical R&D

Key responsibilities

  • The incumbent is to lead an analytical research and development team to conduct R&D activities from early phase, late phase through to commercial phase support for API, formulation product, stability and regulatory CMC authoring, as a part of CMC development or standalone services
  • Ensure the team to meet the preset goal/budget by BU head through streamlining/optimizing the workflow and maximizing the operation efficiency while maintaining full compliance
  • Develop/build a top-notch analytical research and development team including planning, recruiting/hiring, coaching/mentoring, leadership training for staff and manages, provide technical guidance and evaluate new technologies in the field to enhance capabilities
  • Play a leading role in project management, interaction with clients, formulation development, process development and quality assure units, prepare, review and approve quotes or proposals, supervise project review meeting by TC or on-site visits to ensure the projects meet the expected quality and within the desired timelines and budget
  • Independently handle regulatory inspections from FDA, EMA. sFDA etc and GMP audits from clients and internal quality assurance unit
  • Expand business with existing customers and broad the customer basis by participating strategy development and business development activities with BU head

Key requirements

  • Ph.D. degree in Analytical Chemistry or other directly related science discipline with industry experience of over 10 years in Analytical R&D/Quality Control within CMC/pharmaceutical development function; experience in large US or Europe pharmaceutical companies and a minimum of 5 years of managerial experience desired
  • Excellent  managerial experience in both people and projects being able to lead a large team of scientific staff and senior managers and a large portfolio of CMC development and standalone programs
  • Proven 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.
  • Strong technical know-how to guide the team to maintain a leading industry role in analytical development as a contract research organization (CRO)
  • Must be proficient with the requirements of the FDA, EMA and sFDA cGMP regulations, ICH guidelines as well as drug development process
  • Superb communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements

Any applications,pls contact:wang_siyuan@wuxiapptec.com;global_talent@wuxiapptec.com