Operations Support Lead

The company is a global, commercial-stage biotechnology company developing, manufacturing and commercializing novel therapies. It was founded in 2014 in the US and since last year, they are active in East-Flanders (Ghent).They are exploring 4 different technologies to help treat disease. As a global team, they are building a fully integrated cell therapy platform and advancing multiple agents in the process

As a CAR-T Operations Support Lead you will be responsible for the coordination and co-execution of the supporting activities to perform daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment:

• Coordinate, manage and control all quality aspects related to support production activities
• Control in a timely manner production-related QMS documentation (in line with cGMP) in collaboration with MS&T and Quality
• Responsible to escalate production-related matters to Operations Supervisor out of their empowerment zone to ensure timely decision and follow-up
• Work closely and together with support operators to provide guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements
• Act as a SPOC to the logistics warehouse for the material availability in the supporting production areas. Manage inventory in the WIP and storage of cleaning agents.
• Ensure safe and compliant manufacturing operations according to EHS and cGMP procedures and requirements

• Degree in Science, Bio-Engineering, Pharmacy or related field 
• Preferably 1,5 -3yrs years of operational experience within a GMP or ATMP environment in the biotech/(bio)pharma industry.
• At least 1 year experience in leading teams or Project management
• Knowledge of cGMP regulations and EMEA guidance related to logistics or manufacturing and cleanroom behaviors.
• Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Dutch & English

• A contract for an indefinite duration.

• A gross salary (based on level and relevant expercience).

• Meal vouchers • Group Insurance • Hospitalisation Insurance

• Supscription for your smartphone up to maximum 20 euros per month