Operations Expert / Lab technician

Functie

As CAR-T Operations Expert, you will be part of the manufacturing operations team responsible for production of CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment. You will lead and perform multiple units within the CAR-T process operations (i.e. component preparation manufacturing, manufacturing support operations, CAR-T process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. You will work in a team based, cross-functional environment to complete production tasks required per schedule and drive continuous improvement of manufacturing operations leveraging own observation as well as input of junior team members. As CAR-T Operations expert, you need to build and maintain smooth and strong collaborations with Planning, Manufacturing & Process Technology, QC, Maintenance & Engineering, Facility & Utilities, Warehouse and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for junior operators on the production floor. You will work in the GMP Facility in Ghent and report to the Operational Manager, Europe.

Are you interesseted in this role? Call or mail us for a full job discription.

Bedrijfsprofiel:

This company is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Jouw profiel

- Bachelor's or Master's degree in Science, Bio-Engineering, BioTechnology, Pharmacy or related field or equivalent experience required.

- A minimum of 3 years of operations experience within a cGMP or ATMP environment in the biotech/biopharma industry.

- A minimum of 3 years experience in aseptic techniques in clean rooms

- Prior experience in manufacturing, quality, or engineering is required

- Strong influence and relationship building skills with an emphasis on teamwork

- Highly developed organizational skills. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.

- Strong analytical, problem solving, pragmatic and positive critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.

- Can do attitude, Right first time and Hands-on approach

- Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.

- Focus on quality, compliance and detail

- Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors

- Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes

- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.

- Experience working in cGMP systems including PASx, eLIMs, Siemens, and SAP is preferred

- Ability to accommodate unplanned overtime on little to no prior notice

- Ability to accommodate changes in the schedule including working in other shifts, evenings and weekends as per operational needs is required.

- Fluent in English and Dutch.

You will work within a reputable pharmaceutical company active in treating blood and curing people. Committed to quality and driven by excellence, they are committed to improving the lives of patients worldwide. As an operations expert your remuneration will be around 50K on an annual basis

• Biomedische analyses uitvoeren in de: Immunologie
• De klinisch-biologische analyse uitvoeren of de correcte toepassing van de analyseprocedures door de medewerkers controleren
• De eigen deskundigheid ontwikkelen
• De inzameling en verstrekking van bloedproducten aan zorgdiensten bepalen en organiseren

Aanbod

You will work within a reputable pharmaceutical company active in treating blood and curing people.

Committed to quality and driven by excellence, they are committed to improving the lives of patients worldwide.

As an operations expert your remuneration will be around 50K on an annual basis