職位描述
藥物分析
- Job Summary
To supervise the activities of scientific and operational staff responsible for method development/validation projects and analysis of samples.
Serves as a Principal Investigator (PI) for research studies. Take on overall responsibility for the technical conduct of a study, analytical direction, review, documentation and reporting of results. All activities are conducted in compliance with appropriate SOPs and regulatory agency guidelines.
Duties and Responsibilities:
Schedules staff and assigns resources.
Develops appropriate training plans and ensure staff is trained.
Assure staff compliance to SOPs and other regulatory agency guidelines.
Act as front line contact for internal and external clients.
As Principal Investigator (PI), take on overall responsibility for the technical conduct of a study, analytical direction, review, documentation and reporting of results.
Organizes, conducts and evaluates analytical results and testing.
Maintains a clean and safe laboratory work environment.
Participates in process improvement initiatives.
Writes, revises and reviews methods, SOPs and portions of reports and protocols.
Effectively plans and utilizes personnel and resources for timely completion of assigned projects.
Suggests solutions and actions to solve study problems, manages the impact on time and cost, reviews protocol changes and communicates the status of changes to the client.
Participates in client visits.
Assure on-time delivery of high quality data and reports.
Assure that the final report, including any changes, is approved and in compliance with appropriate SOPs and regulatory agency guidelines.
Acts as lead chemist with scientific experiment in support of studies.
Acts as data approver for data generated by project team.
Evaluates SOPs for compliance with regulator guidelines.
Performs other related duties as assigned.
Education/qualifications:
Required:
Bachelor of Science/Arts (BS/BA) degree in chemistry or related scientific field
Experience may be substituted for education.
Ability to perform advanced computer skills (e.g., Word, Excel).
Experience:
Required:
BS/BA degree in science plus at least 7 years or MS degree in science plus at least 5 years of experience. Relevant experience may be substituted for education.
Knowledge of appropriate regulatory agency guidelines.
Experience with use and trouble shooting of analytical equipment is desired.
Basic knowledge of computers and software programs.
Familiar with the use of standard laboratory equipment.
Demonstrates strong organizational and communication skills.
工作地點(diǎn)
浦東新區(qū)徠博科醫(yī)藥研發(fā)(上海)有限公司3號(hào)樓
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許女士/HR
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