Onze klant, een biotech bedrijf, gevestigd in Zwijnaarde, is een wereldwijd biotechnologiebedrijf dat de innovatieve celtheraptie naar Gent brengt. Het team maakt hiermee dagdagelijks het verschil in het leven van vele patiënten die lijden aan kanker en andere levensbedreigende ziektes.
Ze zijn momenteel in een fase van sterke groei en zoeken gemotiveerde en toegewijde teamleden.
Ze zijn momenteel in een fase van sterke groei en zoeken gemotiveerde en toegewijde teamleden.
Operations Supervisor Car-T
Functieomschrijving
As a Operations Supervisor, you are responsible for the daily production process of personalized cell therapy, both for clinical and commercial purposes, in a sterile cGMP environment. You will lead various units within the process and ensure safe and compliant production activities according to cGMP requirements.
Tasks:
Tasks:
- Lead and supervise various units within the process, such as component preparation, production support activities, process, filling & finishing, and cryopreservation.
- Build strong collaborative relationships with various departments, including Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, Procurement & Supply Chain/Warehouse.
- Act as an expert for quality aspects in production activities, including managing and overseeing all documentation and quality-related aspects in cGMP areas.
- Coordinate and manage quality aspects related to production activities, including Change Control Requests, Deviations/events, and CAPA.
- Act as the second point of contact for production quality matters during external audits.
Profiel
Requirements:
- Bachelor’s/Master’s degree in Science, Bio-Engineering, Pharmacy, or related field.
- Minimum 5 years' cGMP/ATMP operations experience in biotech/biopharma.
- 3 years' aseptic GMP manufacturing (grade A/B or C).
- In-depth knowledge of cGMP regulations and EMEA guidelines.
- Strong leadership, communication, and organizational skills.
- Analytical, problem-solving, and positive critical thinking.
- "Can do" attitude with a hands-on approach.
- Experience in Operational Excellence/Lean Manufacturing is a plus.
- Fluent in Dutch and English.
- Ability to work shifts, including weekends.
- Flexibility for unplanned overtime.
Aanbod
- You will join an exciting pharmaceutical company with opportunities for growth.
- You will work within a strong and respectful diverse team where everyone is welcome.
- You will receive an attractive salary package including meal vouchers and eco vouchers.
- Hospitalization insurance, group insurance and bonus are part of the package.
- You work in a 2-shift system (6h - 16h / 14h - 00h) in a regime in which you work 4 days, have 4 days off, etc. This gives you a good balance between work and private life.
- You will work in an environment where loyalty and team spirit are highly valued.
Praktische informatie
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