Process Technology Transfer Lead
Il y a 2 mois
Within our MSAT team in Mont-saint-Guibert (Belgium) there is one position immediately available for a Process Engineer.
***:
**The position**:
The Process technology transfer Lead reports to the MSAT Director. He/She acts as a reference expert at the level of the Company in all aspects surrounding the technology, processes and knowledge transfer workstreams of innovative cell therapies including iPSC-derived technologies. He/She independently designs, plans, and coordinates projects, mentors Scientists and Specialists and generates proposals to meet the corporate strategy.
***:
**Responsibilities & Duties**:
- Evaluate and optimize manufacturing processes to enhance efficiency, scalability, and quality.
- Work closely with process development and manufacturing teams to ensure a smooth transition from process development to full-scale GMP manufacturing.
- Develop and maintain comprehensive documentation, including technology transfer plans, protocols, reports, and standard operating procedures (SOPs).
- Ensure compliance with regulatory requirements, industry standards, and company policies.
- Act as a technical point of contact for Technical Transfer from internal stakeholders as well as external partners ensuring Operational & Scientific coordination.
- Develop and maintain comprehensive documentation, including technology transfer plans, protocols, reports, and standard operating procedures (SOPs).
- Ensure compliance with regulatory requirements, industry standards, and company policies.
- Define, coordinate, plan and control process optimizations and oversee batch failure investigations
- Support process optimizations and batch failures investigations
- Support deviations and CAPA related to process development & tech transfer activities
- Provide scientific coaching of junior profiles
- Work in a constructive and flexible way in project teams
**Qualification & Experience**:
- Education: PhD in Biological sciences or equivalent relevant working experience
- Strong Knowledge and min 5 years’ experience of pharmaceutical GMP and ATMP
- Strong Knowledge and min 5 years’ experience in process development & validation
- Strong knowledge and hands-on experience in technical transfer
- Strong Experience with project management and/or management of external activities
- Industrial experience with biologics, gene and/or cell therapy upstream process development including ownership of key process decisions. Prior experience with different modes of cultivation such as fed batch and perfusion and different technologies (ATF, TFF, G-rex) desired
- Strong organizational, troubleshooting and interpersonal skills along with excellent oral and written communication
- Demonstrated ability to work in a fast-paced, collaborative, and matrixed organization environment.
- Excellent interaction & communication skills, required to work in cross department projects, team spirit
- Work precisely according to procedures, rules and regulations
**Additional skills**:
Since we are working in an international environment; proficiency in English, both written and spoken, is a prerequisite.
As a person, you are open-minded and a good communicator by nature. You have a high level of energy that drives you and inspires your colleagues. You thrive in a changing and dynamic work environment, and in a job that requires you to be flexible, take initiatives and think out of the box when challenges occur. You are a true team-player who enjoys working in close collaboration with colleagues in and out of the laboratory.
**Job Location**:Mont Saint Guibert, Belgium**:
**Position Type**: Full-Time
**Start Date**:Immediately
We offer you a challenging position in a dynamic biotech company with room for personal growth and development. We provide a competitive salary package based on your education and experience.
**Interested?**:
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