Operations Advanced Support Supervisor

As an Operations Advanced Support Supervisor, you will lead and supervise the support operations team responsible for all production support activities (e.g., Grade B cleaning, Material Transfer, Replenishment, Sterilization) and oversee aspects of the CAR-T process operations (Cryopreservation). Your leadership will ensure safe and compliant manufacturing operations according to cGMP requirements, supporting both clinical and commercial CAR-T production. You will collaborate with various internal stakeholders to address production challenges and maintain seamless execution of daily production tasks.

What can you expect?

Here's what you'll do:

• Act as SME for quality aspects related to production activities, ensuring compliance with cGMP regulations and documentation requirements.
• Manage and review documentation in Production zones, including batch records, work instructions, SOPs, and quality-related records.
• Lead and coordinate production support activities, optimizing schedules for efficiency and compliance.
• Support Tech Transfer plans for new production introductions and process optimizations.
• Contribute to the development of manufacturing processes, training, and continuous improvement initiatives.
• Supervise and coordinate personnel, assigning daily production tasks and ensuring operational readiness.
• Implement and lead Tier 1 and Tier 2 meetings to ensure clear communication and task execution.
• Support internal and external audit readiness, representing Support Production in quality matters.
• Ensure safe and compliant operations according to EHS and cGMP standards.

Who are we looking for?

Education:

• Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy, or a related field.

Experience:

• Minimum of 1 year in a cGMP or ATMP environment in the biotech/biopharma industry.
• Minimum of 5 years of direct people management experience overseeing teams of 10+ individuals.

Languages:

• Fluent in English and Dutch.

Strengths:

• Strong leadership skills with the ability to manage and motivate large teams.
• Excellent verbal and written communication skills with a structured and direct approach.
• Ability to manage multiple tasks, prioritize effectively, and integrate cross-functional issues.
• Hands-on, can-do attitude with a focus on continuous improvement.
• High attention to detail and ability to adapt in a fast-paced environment.

Expertise:

• Knowledge of cGMP regulations and EMEA guidance related to cell-based manufacturing.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook); MES/EBR knowledge is a plus.
• Ability to accommodate shift work, including evenings and weekends as required.
• Ability to accommodate unplanned overtime with little to no prior notice.