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.