Director or above for Biological Science
- The incumbent is to lead a Analytical & Stability group (approx. 10 - 20 Scientists) in ASC to conduct analytical and stability activities in early and late phase through to commercialization for biologic drug products
- 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 team for biologics DS and DP stability study including planning, recruiting/hiring, coaching/mentoring, and training for staffs and group leaders. Provide technical guidance/direction to subordinators as well as evaluate new bioanalytical technologies to enhance department capabilities
- Play a leading role in project management interacting with internal and external clients, such as formulation development, process development and quality assure units, etc.
- Prepare, review and approve all analytical related documents, supervise project activities, and manage project meeting by TC or on-site visits. Ensure projects meet the expected quality and within the desired timelines
- Able to handle regulatory inspections from FDA, EMA. CFDA, etc. and GMP audits from clients and internal QA
- Assist senior management to expand business with existing customers and broad the customer basis by participating strategy development and business development activities.
- Ph.D. degree in bioanalytical chemistry, biological Sciences, biology, and/or other directly related science discipline with 5 - 8 years biopharmaceutical industry experience in biologic DS and DP analysis with oversea experience in US or Europe pharmaceutical companies. A minimum of 3 years of managerial experience is desired
- Excellent managerial skills in both people and projects being able to lead a large group of scientific staffs and a large portfolio of Analytical and Stability programs
- Proven good track record of accomplishments in the Analytical R&D and CMC development area-managing different phases of biologic drug product development program desirable.
- Strong biotechnical know-how able to guide the team to maintain a leading role in biologic drug product development as a contract research organization (CRO)
- Must be familiar with requirements of FDA, EMA, CFDA regulations, ICH guidelines and GMP/GLP as well as biologics of drug product development process
- Superb communication skills in written and verbal, and outstanding interpersonal skills are essential job requirements
Any applications,pls contact:email@example.com;firstname.lastname@example.org