The U.S. Pharmacopeial Convention (USP) Director, Reference Standard Laboratory, China lab in Shanghai, China
Director, Reference Standard Laboratory, China lab
Summary of the Position:
This is a hands-on supervisory position responsible for managing reference standard collaborative test, ensure organizational goal completion on time; optimize department management system, empower and satisfy our employees. He/She might be working on developing, reviewing and coordinating management and professional development training programs for USP. RSL-China is one of critical departments for global collaborative testing of USP reference standard. This position has impact on availability of USP reference standards, and therefore, it has global impact on USP’s mission to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods, excipients
Roles and Responsibilities:
Set department annual project goals and closely control project progress and output
Manage all activities in RSL including scientific decision-making and daily operation, and ensure on-time project delivery and organization goal completion. Ensure the overall quality of the lab work
Play key role to control risk and track project status for department. Lead scientific discussion within department where project has technical difficulties and resolve the technical issue.
Correctly handle and solve employee risk. Creates and distributes detailed project status reports to division leader to facilitate decision making about department capabilities of
Promote the USP brand and impact by close interaction with industry and other regulatory agencies, applies expert knowledge of current trends in public health to prepare professional presentation for advocate USP mission.
Coordinates external compliance regulatory stakeholders, vendors and internal supporting group to ensure final product at a high level of quality combined with overall value to USP.
Develops monitors and reports on the effectiveness of productivities by establishing relevant evaluation metrics and collection capabilities; demonstrates use of quality improvement in daily work and operations.
Proactively communicate with other departments include scientific evaluation group for projects assessment including evaluation of technical capability, manpower, and timeline. Communicate with senior management and coordinate with other functions to maintain a healthy project pipeline
Set and control the budget for operation of RSL. Ensure operational efficiency in routine testing activities. Making effort to improve daily lab supplier expense control.
Identify the training needs and prepare technical modules to ensure team productivity and quality requirements. Each year has a training goal to the department to ensure each team member technical skill scope expanded and team technical skill capability improved.
Keep abreast of the latest analytical technology in industry and regulation requirements.
Work with other functions to identify capability improvement opportunities for RSL and make plans for implementation. Work closely with other Laboratories on resource sharing and adjustment as needed.
Qualified as trainer to teach USP Pharmacopeial Education courses as appropriate.
Ensure laboratory environment are safety and compliance. Frequently monitor and report related activities, events and EHS issues where appropriate. Once a week lab EHS related check be performed and recorded and filed.
Collaborate with USP corporate and global sites staff in various technical, SMPO, and program unit teams and functions to ensure RSL running smooth
Basic Qualifications (formerly Minimum Requirements)
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 8 years hands on R&D experience of analytical method development and validation in drug substance (API)/drug products (finished dosages) and/or specialty chemicals are required.
More than 6 years of supervisory experience is required.
Knowledgeable in implementing management tools in project progress control and employee risk control
Hands on experience in creating management system to measure employee productivity and efficiency
Preferred Qualifications (formerly Knowledge, Skills & Abilities)
Degree in Chemistry or pharmaceutical major.
Prior experience in a pharmaceutical scientific based R&D area, such as Drug substance in-process –control and drug product development and drug product formulation analytical support.
The ability to make decision independently and collaboratively without direct authority.
Hands on experience in drug substance and drug product development analytical method development process and method validation
Familiar with ICH, FDA and USP all regulatory request, and knowledgeable in GMP and ISO17025.
Results driven with demonstrated successful outcomes.
Willing to learn and develop leadership capability within organization
Ability and desire to work well with diverse employees and stakeholders in a cooperative and friendly manner.
Ability to handle multiple priorities in a fast-paced environment.
Excellent written and verbal communications skills and presentation skill both in English and Mandarin
Able to work flexible hours when needed, especially early or late in the day during the business week.
This position has three direct reports: RSL managers.
Shanghai, Shanghai, China
Job Category Laboratories