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The Scientist II, specializing in Cell Biology, will assume a leadership role in driving verification and validation (V&V) activities for the development of innovative instrument systems in the field of cell and gene therapy. This pivotal position is instrumental in ensuring that the instrument system meeting all product and customer requirements.
In this role, you will
- develop, plan, and implement V&V strategies for a new instrument system.
- take charge of coordinating and leading V&V activities throughout the entire product development process; ensuring that all V&V processes align with industry regulations and quality standards.
- engage in various aspects of product development, including designing and conducting experiments during feasibility testing, developing test protocols for V&V, planning and completing testing, and participating in usability studies.
- 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 laboratory operation.
- demonstrate the ability to independently design and complete experiments, perform data analysis and problem-solving, and effectively present results to internal collaborators.
- maintain comprehensive and precise records of all V&V activities, ensuring a thorough documentation of the processes involved.
Keys to success
I. Education
- Master’s Degree with 2-3 years’ experience or PhD with 0-1 years’ experience in Cell Biology, Immunology, or a related field.
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 with excellent organizational and multitasking skills
- Strong problem-solving skills to address issues that may arise during V&V processes
- Understanding of quality management systems and regulatory affairs is an advantage
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