Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

How 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