Analytical Development and QC director
- The incumbent is to lead an Analytical Development and QC group (approx. 20 - 40 Scientists) in ADQC to conduct all analytical development and quality control activities from early phase to late phase support for 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 development and QC 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 or equivalent 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; 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 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.
- 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 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.
Any applications,pls contact:Cui_yining @wuxiapptec.com;firstname.lastname@example.org