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Work Schedule
Standard (Mon-Fri)Environmental Conditions
Laboratory SettingHow Will You Make an Impact
The Scientist II, Cell Biology will be responsible to lead verification and validation (V&V) activities for the development of new instrument systems in the field of cell and gene therapy. This role is pivotal in ensuring that the instrument system meets all product and customer requirements. The preferred candidate should offer technical expertise at both the project and department levels and should seamlessly integrate into a dynamic and multidisciplinary team. This Scientist should demonstrate a result-oriented approach and the capacity to excel in the fast-paced realm of biotechnology. The successful candidate will bring substantial practical experience in cell biology, particularly in genetic engineering of immune cells and iPSCs, and familiarity with bioanalytical tools such as flow cytometry, digital PCR and quantitative PCR, etc.
What will you do
Develop, plan, and execute V&V strategies for new instrument system. Take charge of coordinating and leading V&V activities throughout the product development journey.
Engage in various aspects of product development, encompassing tasks like designing and conducting experiments during feasibility testing, developing test protocols for V&V, planning and executing V&V, and contributing to usability studies
Ensure that all V&V processes align with industry regulations and quality standards
Work closely with R&D scientists and multidisciplinary teams to understand product requirements and design efficient test protocols
Play a direct role in the maintenance of cell culture and contribute to overall laboratory maintenance.
Demonstrate the ability to independently design and execute experiments, perform data analysis and troubleshooting, and present results effectively to internal stakeholders
Maintain comprehensive and precise records of all V&V activities
How will you get here
I.Education
Required: Bachelor's degree in Cell Biology, Immunology, or a related life sciences with 4 years of relevant experience or Master's degree in a related field with 2-3 years of relevant experience.
Fresh PhD graduates are also welcome to apply.
II.Experience
In depth knowledge and hands-on experience in cell biology techniques, with a specific focus on primary human cell culture including T cells and NK cells, and prior experience with iPSCs
Familiarity with the principles and operation of instrument systems used for genetic engineering of immune cells. This includes understanding of technologies like gene editing, CRISPR-Cas9, and associated equipment
Familiar with fluorescence-based detection platforms like flow cytometry, dPCR and qPCR instruments
Prior working experience in immunotherapy, stem cell, or hematology research is considered as a valuable advantage
Prior experience working in a regulated environment such as a ISO-certified laboratory, is considered as a valuable advantage
III.Knowledge, Skills, Abilities
Strong laboratory skills, meticulous record-keeping, and data analysis abilities to ensure accuracy and quality of V&V results
Proficiency in Excel and Statistical Data Analysis
Excellent verbal and written communication skills
Excellent organizational and multitasking skills
Strong troubleshooting skills to address issues that may arise during V&V processes
Understanding of quality management systems and regulatory affairs is an advantage
Thermo Fisher Scientific Inc. is an American supplier of scientific instrumentation, reagents and consumables, and software services. Based in Waltham, Massachusetts, Thermo Fisher was formed through the merger of Thermo Electron and Fisher Scientific in 2006. Thermo Fisher Scientific has acquired other reagent, consumable, instrumentation, and service providers, including: Life Technologies Corporation (2013), Alfa Aesar (2015),Affymetrix (2016),FEI Company (2016), BD Advanced Bioprocessing (2018),and PPD (2021).
As of 2017, the company had a market capitalization of $21 billion and was a Fortune 500 company. Annual revenue in 2021 was US$39.21 billion.
In March 2020, Thermo Fisher Scientific received emergency use authorization from the FDA for a test for SARS-CoV-2 to help mitigate the COVID-19 pandemic.
Job ID: 148465931
Skills:
Elisa, Molecular Biology, adherent cell culture, 3D cell culture models, protein chemistry, facs, sds-page, Flow Cytometry, cell-based functional assay, Western Blotting, Cell engineering, confocal microscopy, NGS analysis, Molecular Cloning, QPCR, stable cell lines development, Protein Expression, suspension cell culture
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