Senior Production Manager
Exo Biologics is a biotechnology company in Belgium focusing on researching and developing novel therapeutic candidates based on Exosomes, known as extracellular vesicles. It has been known that its biological functions include intracellular communications between the cells, transfer of proteins, lipids, genetic material and signaling to the recipient cell via cell-surface or endosomal receptors.
Currently, EVs have been studied to be used as drug delivery systems for therapeutic delivery due to the fact that they can across the blood–brain barrier.
Exosomes are gaining momentum in the scientific community as potential alternatives to stem cell therapies. In recent years, there has been an increasing number of publications related to the unlimited applications areas which can be used for prognosis, for therapy, and as biomarkers for health and disease.
Exo Biologics has strong partnerships and influential networks for collaborating and researching new medical treatments, including research centers, public universities, and private partners. Our primary mission is to provide affordable and accessible therapies to patients with unmet medical needs.
- Setting up GMP clean rooms.
- Implementation of GMP production process.
- Technology-transfer of the process and product development of extracellular vesicles.
- GMP production process of extracellular vesicles biologic drugs.
- Compliance with EXO Biologics quality management system.
- Compliance with the EU and national regulations and laws.
- Coordinate routine lab work and other activities related to the production process including Quality Systems, Quality Control, Management of Facilities, Equipment and Materials.
- Monitor production process and performance, data recording and storage.
- Review and sign-off all documents related to the production process, including data recording.
- Contact with products suppliers, device suppliers and technical maintenance teams.
Communication & Training Activities
- Participation in relevant trainings (internal and external).
- Participation in meetings & data presentation to clinical partners, research partners, auditors, regulatory authorities.
- Identify, address and document all deviations and implementing corrective actions as appropriate.
- Overseeing installation of new equipment, maintenance, calibration and repair of the system.
- Data recording and management following EXO Biologics quality system and GMP guidelines.
- Possession of diploma or other formal qualification in the field of medical or biological sciences. PhD, MD, Master or equivalent academic degree.
- Minimum 5 years’ practical (hands-on) experience in research laboratory.
- Experience with cell culture or human cells is required.
- GMP-compliant production systems.
- Experience with cell culture (establishing cultures from cryopreserved vials, maintaining sterile culture, counting, passaging).
- Experience with the quality management system.
- Very good understanding of laboratory safety rules and universal precautions.
- General computer skills, including the use of MS office.
- In-depth understanding of cell culture process and related techniques.
- General understanding of quality management principles.
- Knowledgeable in the development, implementation, maintenance, improvement of quality management systems
- Problem – solving skills.
- Excellent communication and managerial skills.
- Work under time pressure.
- Very good English .
- You will report directly to the Head of Production.
- Exo Biologics offers you a complete and competitive salary package.
- Part of a promising start up company.
- Every day brings new challenges and new things to learn.
The employee will be required to work in the R&D facilities in Niel for 2020 and be flexible to work from 2021 onwards in the facilities in Liege.
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+32 471 793 953