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Quality Engineer

hays-nl - Amsterdam
Quality EngineerAmsterdam | Quality Engineer | MES Specialist | PAS-X | Project Support | GMP | 1047688Your new company Kite, a Gilead company, is dedicated to achieving one of the most ambitious goals of 21st century
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Sr. Cell Therapy Specialist

Oxfordcorp - Amsterdam - 03-08-2023 Naar vacature  

Our client, a leading company in the field of innovative NK cell therapies, is seeking a Cell Therapy Specialist to join their dynamic team based in Amsterdam, the Netherlands. This role is essential for the production of their unique PM21 particle, enabling the growth of high-dose NK cells and contributing to groundbreaking therapies in immuno-oncology and beyond.

Job Description:
As a Cell Therapy Specialist (also internally referred to as Sr. Production Technician), you will be an integral part of the team responsible for manufacturing the PM21 particle. In addition to ensuring consistent process execution and high-quality output, you will actively support the development of process improvements and next-generation manufacturing processes. Your contributions will play a crucial role in delivering our therapies to patients. Key responsibilities include:

Preparation and execution of manufacturing runs in accordance with approved master batch records and standard operating procedures (SOPs)
Ensuring consistent and high-quality process execution
Accurate completion of manufacturing documentation, including non-conformance reports and recording unusual results
Adherence to SOPs and relevant cGMP regulations during manufacturing
Maintaining optimal cleanliness and organization of the cleanroom/production area
Collaborating with the Process Development team to facilitate manufacturing process development
Supporting process development studies through preparation, execution, and documentation
Assisting with technology transfer activities
Acting as a backup for the warehouse assistant, handling deliveries, shipments, storage of goods, and administrative tasks
Supporting investigations, root cause analyses, and process changes resulting from non-conformances or continuous improvement activities

Requirements:
To excel in this role, we are looking for a candidate with a passion for cells and process technology who thrives in a dynamic environment. The following qualifications and experience are required:

BSc or MSc in cell biology, biotechnology, bioprocess technology, or a related field
Minimum of 2 years of relevant working experience, preferably in
industrial
cell therapy, vaccines, or up-/downstream biologics manufacturing
Hands-on experience with cell culture, including knowledge of relevant process equipment
Availability to work some weekend days on a regular basis and to participate in regular on-call service (incidentally)
Ability to comply with procedures and regulations, with a good understanding of GMP (experience in GMP production is a plus)
Excellent planning and organizing skills
Strong team player with effective communication abilities
Strong sense of quality and ownership
Professional proficiency in English (written and verbal), knowledge of Dutch or other languages is a plus

Benefits:
Start on a 6 month contract through Oxford Global Resources - extension possible
Salary; €3.000 - €5.000,- gross a month based upon a full time, 40 hour, workweek
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