CAR-T Operations Supervisor

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

The CAR-T Operations Supervisor is an exempt level position working within Technical Operations team responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment; on an assigned production shift schedule

The CAR-T Operations Supervisor will lead and supervise 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 need to build strong partnerships with Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, Procurement & Supply Chain / Warehouse 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 technicians and experts on the production floor.

• Coordinate, manage and control all quality aspects related to production activities and production of batches in cGMP areas
• Manage and review in a timely manner « documentation » activities in Production zones (incl. Procedures, work instructions, logbook, transfer forms…)
• Edition and review of executed batch records (paper doc & MES)
• Conduct routine and non-routine (spot checks) inspection on documentation in the production zones
• Write or revise and control in a timely manner production-related QMS documentation (in line with cGMP) in collaboration with MS&T and Quality
• Change Control Requests (CCR), Deviations/events, and CAPA
• Master Batch Records of products and preparations, SOPs and associated documents, cleaning validation, shut down and media fill simulation protocols and reports
• Review cGMP documents generated by the Production for technicians and experts before review by QA
• Manage and communicate KPI’s related to quality aspects in Production
• Production SME for internal & GMP inspections in collaboration with QA (back-up of Operations manager)
• 2nd point of contact representing Production quality matters in external audits
• First line communication with QA Ops for quality matters; and responsible to escalate production-related matters out of their empowerment zone to ensure timely decision and follow-up

• Master’s degree in Science, Bio-Engineering,Pharmacy or related field or equivalent experience required.
• A minimum of 5 years of operations experience within a cGMP or ATMP environment in the biotech/biopharma industry.
• At least 3 years of aseptic GMP manufacturing experience (grade A/B or C).
• Knowledge of cGMP regulations and EMEA guidance related to manufacturing of cell-based products and cleanroom behaviors.
• Must exhibit strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management.
• Ability to work independently and successfully; prioritize and manage multiple tasks simultaneously; integrate cross-functional issues and balance competing priorities effectively.
• 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
• Tenacity to drive issues until resolved and deliver results
• Self-motivated enthusiastic personality team player
• Flexible mindset capable to deal with ambiguity and to respond quickly; energetically; and enthusiastically to changes
• Self-motivated enthusiastic personality team player with a desire to learn new skills and train juniors
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• A working leader who can participate in production runs in critical situations when needed.
• Excellent communication and organizational behaviors skills are required.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
• Proficiency with MES/EBR is a nice to have
• Ability to accommodate shift work including evenings and weekends as required by the process.
• Ability to accommodate unplanned overtime on little to no prior notice
• 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