Functieomschrijving - Management of quality control activities (planning, working instructions, reporting, results validation)
- Ensure compliance to GMP requirements and laboratory procedures
- Involvement in the analytical method development, qualification and validation
- Writing, reviewing of protocols and reports related to QC activities
- Managing logistic tasks related to QC activities (agreement with subcontractors, follow-up of subcontracted activities)
- Provide leadership to work on development and continuous improvement of the QC testing assays.
- Participate in the definition of industrial requirement for process in(at)-line QC testing assays in cGMP environment (technical and functional specifications).Profiel - Master or PhD in Medical Science or related biological field
- At least 5 years practical experience in QC, batch release management, methods validation and development (Biotech field mandatory – cell therapy asset)
- Minimum 5 years of practical experience in the pharmaceutical industry in a GMP environment
- 5 years of experience in a people management role
- Very good communication skills both in French and English (writing scientific documents, reports, protocols and mails, phone conferences, contacts with clients)
- Very good theoretical knowledge and practical experience in cell culture including bioassays, immunoassays (ELISA, Flow cytometry, immunohistochemistry), molecular biology (QPCR) are mandatory
- Knowledge of stem cell biology is a plus
- Excellent communication skills
- Strong organizational skills with ability to manage projects through wise planning, time optimization, detail orientation and prioritization
- Ability to deal with multiple and changing priorities
- Ability to train and mentor staffOrganisatie- en afdelingomschrijving Our client is an innovative biotech company, based in the Walloon Region.Aanbod - A full-time permanent position (40h/week) in a growing team.
- To work in a human-sized, dynamic, respectful and professional environment.
- The opportunity to take part in a challenging scientific and business growth.
- An attractive salary package in line with the position responsibilities and your experience.