The U.S. Pharmacopeial Convention (USP) Associate Lab Manager, RSL - USP China in Shanghai, China
Associate Lab Manager, RSL - USP China
Summary of the Position:
This is a supervisory position responsible for successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS) collaborative testing. The incumbent will provide technical leadership in analytical scientific area as well as staff development and mentoring. He/She is responsible for the training, development, and management of a group of scientists who primarily work on reference standards collaborative testing. He/She will utilize his/her technical expertise, knowledge of the pharmaceutical reference standard development process and current regulatory guidelines, and strong organizational and communication skills to ensure development or release of high quality reference standard materials on time.
Roles and Responsibilities:
Leads, manages, and directs group activities (project review, collaborative testing protocol review, troubleshooting of analysis methods, and communication with internal and external customers). Develops and mentors staff not only in USP-related duties but also in scientific expertise, communication, and workplace relationships.
Ensures test protocols, SOPs accurately reflect current processes and team members adhere to the protocol, monograph and SOPs strictly.
Works with QA to lead the continuous improvement of processes, develops and integrates internal and external best practices into processes to deliver results with high quality. Play leading role in the investigation of atypical data through the use of root cause analysis.
Ensures consistency, timeliness, and the highest quality in all group outputs. Sets group priorities and holds employees accountable for results, and ensures short/long term goals are set and met within timelines. Facilitates the accomplishment of key departmental metrics.
Reviews and approves training documents, SOPs, and internal/external reports and communications.
Represents the department and provides scientific expertise at internal and external meetings.
- BS or higher degree in Chemistry or relevant field.
- Associate Manager: Ph.D. with 3 years of analytical chemistry lab experience, or 6 year for MS, or 9 years for BS;
Knowledge, Skills and Abilities:
Must be dedicated, energetic and willing to provide leadership.
Must have demonstrated a comprehensive understanding of the analytical science and familiarity with analytical instrumentation
Previous success as a manager in an analytical laboratory with experience in training and developing subordinates is essential.
Previous R&D experience working in API or drug product manufacture with solid knowledge and hands on experience of Analytical method development and analytical method validation is preferred.
Excellent technical writing and verbal communication skills in English are required.
Good interpersonal skills and proven ability to function in a team-oriented environment are necessary.
Strong decision making and initiative attitude is essential.
Shanghai, Shanghai, China
Job Category Laboratories