The U.S. Pharmacopeial Convention (USP) Director, Compendial Development Lab, USP China in Shanghai, China
Director, Compendial Development Lab, USP China
Summary of the Position
This is a hands-on supervisory position for a team of scientists responsible for supporting the development of new or modernized monographs and general chapters in USP-NF. The Director collaborates with USP scientific staff for identifying and prioritizing projects, determination of technical approaches, and communication of results, and in house developed monographs and/or modernization of monograph procedures, and general chapters as an alternative to industry sponsored monographs and procedures. The incumbent provides oversight and direction for one or more team leaders or managers who have technical supervisory responsibilities for work aimed at monograph modernization and monograph development and ensures alignment with departmental goals, and USP’s Strategic Plan, mission, and vision. The incumbent is responsible for the collaboration between CDL-China and other global and local functions to implement the strategy aligned with the appropriate Program Unit.
Roles and Responsibilities
Support USP China Site Leader to develop China Strategy and site expansion plans
Develop and control annual budgets, project resources, capital, personnel needs for CDL
Monitor and manage all activities with action orientation, initiation and urgency in CDL or other department to ensure on time project delivery for organization goal completion
Communicate with GLO’s senior manager, science program unit and other functions to maintain a healthy project pipeline
Identify, organize and provide the resources to develop the team members’ knowledge, technical skills and capabilities to ensure productivity and quality requirements for CDL and potential another group
Keep abreast of the latest analytical technology in industry and regulation requirements
Develop and deliver USP Pharmacopeia Education courses and instructor
Collaborate with USP corporate functions and global sites to support CDL running smoothly
Perform other duties as assigned.
Tracks project status for department. Creates and distributes detailed project status reports to all staff in department to facilitate decision making about new project assignments.
Develops, monitors and reports on the effectiveness of programs by establishing relevant evaluation metrics and collection capabilities; demonstrates use of quality improvement in daily work and operations.
Ph.D. with minimum of 10 years, or MS with 15 years of broad analytical chemistry laboratory experience or equivalent professional experiences in the pharmaceutical and related industry.
More than 5 years oversea pharmaceutical industry hands on working experience in drug product development, drug substance development, and formulation development analytical support.
Experience in lab instrument metrology (incl. sample management, instrument metrology experience, etc.)
Rich experience in overviewing of lab operations.
Strong people management capabilities to lead a sizable lab scientists and lab managers in different functions (approx. 40 people)
Broad technical expertise covering both R&D, QC and instrument metrology, compendium verification program
Effective problem-solving skills, be a key role of scientific decision making in R&D project technical problem solving
Capable of influencing others and be able to make rational and mature decisions
Demonstrate solid scientific and pharmaceutical regulation understanding
Deep understanding of safety, custom clearance, EHS and other regulatory requirements
Familiar with Lab management tool implementation and hands on experience in analytical project progress control and project risk management
Must be able to multitask priorities in a fast-paced environment.
Must be able to motivate the team with can-do attitude
Excellent oral, written, and presentation skills in both Mandarin and English
Must be familiar with GMP and/or ISO 9001 environment
Familiarity with ISO 17025 is a plus
The ability to work flexible hours when needed without direct authority.
- Lab managers and scientists
Shanghai, Shanghai, China
Job Category Laboratories