PlusOne

Production Manager - Biotech - Liège

Company

Our Client is a is an innovative biotechnology company in Belgium focusing on researching and developing novel therapeutic candidates based on Exosomes, known as extracellular vesicles. Exosomes are gaining momentum in the scientific community as potential alternatives to stem cell therapies. The company has strong partnerships and influential networks for collaborating and researching new medical treatments, including research centers, public universities, and private partners. Their primary mission is to provide affordable and accessible therapies to patients with unmet medical needs. The company is currently located in Niel (Antwerpen) and will move in the area of Liège.

Role

You are looking for a professional challenge that allows you to work in a start-up environment in order to participate to the development of production activities?

You want to bring your expertise in cell culture and Clean Room environment in order to face the different challenges? You want to endorse polyvalent responsibilities (R&D and production) in order to contribute to a scaling-up phase?

Plus One can offer you this great challenge:

Your key responsibilities:

GMP production

• 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 company 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 training's (internal and external)
  • Participation in meetings and data presentation to clinical partners, research partners, auditors, regulatory authorities

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
  • Data recording and management following company quality system and GMP guidelines

Profile

Eduction :

PhD or Master degree in the field of medical or biological sciences.

Experience

  • Minimum 5 years’ practical (hands-on) experience in research laboratory
  • 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

Competencies

  • Knowledgeable in the development, implementation, maintenance, and improvement of quality management systems
  • Problem - solving skills
  • Excellent communication and managerial skills
  • Work under time pressure
  • Very good English and French, Dutch is a plus.

Offer

Our Client offers a full-time permanent position along with an attractive remuneration package.

The position is currently based in Niel (Antwerpen) but the candidate has to be flexible to work from 2021 onwards in the facilities in Liège.

Publication date

30.07.2020

Contact person

Gaëlle Minet

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