The QC Scheduler is a position with responsibilities within QC area related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Major Responsibilities
1. Develop and oversee the planning of the execution, documentation and review of QC IPL analyses and EM sampling (routine, OOS/OOT/investigation analyses, proficiency testing, equipment calibration/performance checks) in order to meet the production schedule.
2. Closely work together with the QC Supervisors to find solutions to urgent or unplanned problems, set up a system of standard work and plan the qualification of the QC/EM analysts. The QC Scheduler, CAR-T Manufacturing highlights the planning risks to the CAR-T QC Supervisor and mitigates these well in advance to ensure business continuity.
3. Closely work together with Maintenance & Engineering to check the availability of the equipment, maintain the compliant state of the equipment and plan the assist in the troubleshooting if needed.
4. Closely work together with Planning and Manufacturing Operations to define the timing of the samples, the occupation of the cleanrooms etc.
5. Providing the necessary consumables and reagents to the lab in cooperation with the logistic center / Warehouse.
6. Ensure and implement controls in managing the consumables and reagents inventory to minimize discards and/or scrap in collaboration with the logistic center / Warehouse.
7. Prioritize the use of resources to most effectively achieve business goals and within budget.
8. Participate in regular Vein-to-Vein, Site Supply Chain and Operations meetings (e.g. Production Ramp Up plan) to evaluate constraints and evaluation of QC priorities to meet site production targets.
9. Set up and report performance metrics (e.g. % of tests released on time, % of retests).
10. Available for other duties and demonstrate willingness to learn new skills as required.
Qualification
Education
1. Bachelor’s or master’s degree in Science, Bio-Engineering, Pharmacy, Biotechnology, FBLT, MLT or any other related field or equivalent experience required.
Experience
1. A Minimum of five (5) years of experience in a laboratory function within an industrial manufacturing or regulated environment. Experience in a QC lab in a controlled pharmaceutical environment is preferred.
Capabilities, Knowledge, and skills
1. A passion to make the difference in the life of patients.
2. Proven planning capabilities.
3. Must be responsible and able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to colleagues.
4. The candidate must be highly organized, responsible and capable of working in a highly regulated environment with a positive attitude under limited supervision.
5. Working knowledge of biotech analyses and EM sampling.
6. Excellent interpersonal and written/oral communication skills, teamwork oriented. Must exhibit ability to convey information to management.
7. Ability to interact with all levels within the organization and build strong partnerships with other departments.
8. Ability to pay attention to details and follow procedures.
9. Proficient with using basic computer software packages and Microsoft Office applications (Outlook, Excel, Word and PowerPoint).
Language(s):
Dutch and English
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