諾佛葛生技顧問股份有限公司
English Required
Flow & Cell-Based Assay Scientist (Clinical Lab Service)
10/18 Updated
Full-time
Senior Level
English RequiredSalary & Location
Monthly SalaryNT$ 53,000~70,000
台北市南港區
Required
Language Requirements
English
聽/中等、說/中等、讀/中等、寫/中等
Work Experience
3年以上
Job Description
Job Summary：
As a member of Central lab team, you will be supporting the start-up of a cell-based assay and flow cytometry analysis. You will help define the requirements for validation and will establish processes under line manager's supervision that will enable the Central lab to operate successfully with regard to the analysis and characterization of cell-based therapies or vaccines; specifically as a flow cytometry scientist. This role provides the opportunity to closely partner with the vaccine development and clinical trials as you define and execute the start-up activities associated with establishing flow cytometry / cell-based assay capabilities and expertise at Central lab.
Responsibilities include flow cytometry / cell-based assay method development, validation, qualification, transfer and troubleshooting. In addition, the candidate will be expected to write the validation / analytical protocol and report. Additional responsibilities include validation of computer systems, and management/administration of equipment (e.g. instrument, etc.).
General Responsibilities:
1.Collaborate with external groups to identify technology and business processes that will establish flow cytometry / cell-based assay expertise at Central lab.
2.Conduct analysis work following related SOPs and guidance.
3.Review data and evaluate against established acceptance criteria
4.Define requirements for laboratory equipment and support purchasing.
5.Evaluate data to identify trends and/or establish limits
6.Participant in discrepancy investigations and corrective actions
7.Receive and provide training
8.Lead assay development, transfer and validation activities
9.Write, review or approve equipment qualification/maintenance life cycle documents
10.Draft, check, review or approve documents, such as SOP, protocol, analytical result, report and method.
11.Write protocols and reports under limited supervision
12.Assure and apply GCP/CAP throughout operations
13.Participate in CAP/GCP/GLP/ regulatory related training courses.
14.Support internal, external, and regulatory inspections
15.Work to meet schedules, timelines, deadlines
16.Participate in and/or lead projects and process improvements
17.Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc.
18.Provide input or set personal performance goals and departmental objectives Establish work priorities to meet targets and timelines; manage competing priorities Other tasks assigned by line manager.
Clinical Lab Service Scientist
1.Participate in and/or lead projects and process improvements
Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc.
2.Provide input or set personal performance goals and departmental objectives Establish work priorities to meet targets and timelines;
3.Manage competing priorities Other tasks assigned by line manager.
Number of Openings
1~1人
Educational Requirements
大學(學院)以上
Field of Study Requirements
醫藥衛生學科類
Work Schedule
日班
Leave Policy
週休二日
Job Category
Biological Researcher
Laboratory Technician
Biotechnology Research and Development Staff
台北市中山區
其他醫療保健服務業
Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific providing clinical development services across all clinical trial phases and therapeutic areas, including an in-house and integrated global product development and regulatory affairs consultancy, BioDesk.
Working in a fast paced and adaptable environment, we set a high benchmark for clinical trial operations by listening carefully, allocating Asia Pacific’s best people and talent, and leveraging best in class platforms, technology, systems and processes to meet our client’s clinical program goals and ultimately improve patient lives.
Our people are critical in meeting organisational and client’s objectives and we place a strong emphasis on creating an inclusive, collaborative, transparent and collegiate work environment where everyone is supported to be the best they can be. We support our employees with financial assistance to enable flexible working arrangements, paid parental leave for primary and secondary carers, and regular training, learning, and international knowledge-sharing opportunities.
Suitable Jobs for You
