Open position by Exo Biologics: Senior Researcher / 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.

KEY RESPONSIBILITIES:

– Production and R&D:
• Responsible for process and product development of extracellular vesicles
• Implementation of GMP production process
• GMP production process of extracellular vesicles biologic drugs
• Compliance with the EU and national regulations and laws

– Staff management:
• Supervise personnel including scheduling of tasks and project-related work as well as overseeing execution of procedures according the QMS
• Manage the training of staff and their continued strict adherence to standard processing practices
• Coordinate routine lab work, experiments and other activities related to the project with other operational functions including Quality Systems, Quality Control, Management of Facilities, Equipment and – —

– Materials
• Monitor project performance, data recording and storage
• Review and sign-off all QMS documents, including data recording FORMs

– Training:
• Participation in the trainings, workshops and scientific congresses

– Partnering:
• Contact and collaboration with clinical partners, research partners, auditors, product suppliers, regulatory authorities
• Collaborate and contact with other test sites and third parties involved in the project

– Quality management:
• Identify, address and document all deviations and implementing corrective actions as appropriate
• Overseeing installation of new equipment, maintenance, calibration and repair of the system
• Draft and approve Interim and Final reports
• Raw data archive management

PLACE WITHIN THE COMPANY
• Employee will be the head of the GMP production unit
• Report to General Manager

EDUCATION REQUIREMENTS
• Possession of diploma or other formal qualification in the field of medical or biological sciences. PhD, MD, Master or equivalent academic degree.

EXPERIENCE
• Minimum 5 years’ practical (hands-on) experience in research laboratory
• GMP-compliant production systems
• Experience with 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

COMPETENCIES
• Knowledgeable in the development, implementation, maintenance and improvement of quality management systems
• Problem solving skills
• Good communication and managerial skills
• Work under time pressure
• Very good English

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