EXO Biologics is a clinical-stage biotechnology company focusing on developing innovative extracellular vesicles treatments. Our mission is to provide affordable and accessible extracellular vesicles (EVs) therapies to patients with unmet medical needs.
Exo Biologics is currently hiring a Production Specialist responsible for
- Production of development, pre-GMP and GMP EVs lots
- Process improvement of R&D EVs production processes
- Scale-up pre-GMP production processes
As an ideal candidate, you
- Have a thorough knowledge and experience in cell culture GMP production environment.
- Want to work in between R&D and Production environment according to strict procedures.
- Want to help patients with new medicines based on EVs.
List of responsibilities and activities
- Carrying out process and development projects of new EVs therapies into a GMP environment.
- Carrying out all manufacturing activities, from starting material to the final product, according to relevant procedures.
- Preparing the exosome production platform and the facility for routine manufacturing.
- Preparing for the qualification runs: trainings, materials, qualified equipment, initiating a qualification protocol.
- Carrying out the qualification runs, reporting in batch records and finalizing in a qualification report.
- Integrating existing APV batch records into the QMS of the new facility.
- Carrying out the APVs, reporting in batch records and finalizing an APV report. Initiation and follow-up of deviations, CAPA and changes.
- Training new production operators.
- Bachelor, Master or PhD degree in biochemistry/biology/biotechnology or related field.
- At least 1 year of production experience in cell culture and GMP. Experience with EVs is even better.
- Process development proved experience. Applied “design of experiment” is even better.
- Good communication skills (verbal and written) in English.
- Team player, accurate, well organized, problem-solving, troubleshooting, result-driven, attention to detail, flexibility.
- Full-time (40hr/week)
- Extra benefits provided by the company: Car, Smartphone, DKV, Pension plan, Meal voucher.
- Job Location: Antwerp (Q2 2023) – Liège (From Q3 2023 and after)