Technology Transfer Engineer
Publication date:13 août 2022
Place of work:Route de Crassier 13, 1262 Eysins
Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced. Quotient has two key product portfolios, Alba by Quotient and MosaiQTM by Quotient. The Alba by Quotient product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ™ is designed to be a game-changing solution, which we believe will increase efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins/Switzerland, Edinburgh/Scotland and Chicago/Illinois.
Technology Transfer Engineer
Quotient is recruiting for a Technology Transfer Engineer to join the Technology Transfer Team based in Eysins. The role is a full-time and a permanent position.
The Technology Transfer Engineer role consists in the transfer of new design from R&D to Manufacturing.
Design to be transferred applies for the manufacturing of in vitro diagnostic microarray, the processing formulation and storage techniques of red blood cell, or the purification and/or formulation proteins.
The role implies to bring a technical and/or scientific expertise on the development of manufacturing processes taking into consideration the design for manufacturability and design for testing.
Consequently, the role implies to plan, organize, and drive activities with all stakeholders such as MSAT, Quality, Validation, and Supply Chain as well as the Development department in Edinburgh, Scotland.
The main responsibilities will include:
- Integrate manufacturing requirements along design development
- Participate in the review of data and documentation from the Development team such as development protocol and report
- Plan and track tech transfer activities
- Organize and lead meeting with all stakeholders
- Communicate through presentation tech transfer strategies, plan, and status
- Contribute to the generation of all documentation needed for the implementation of manufacturing processes within GMP environment such as process map, risk analysis, working instruction, BMR, and specifications.
- Take part in the generation of manufacturing recipes (MES and ERP)
- Participate and contribute to the validation protocol and report
- Collect and analyze process parameters data and Quality Control (QC) analytics from Development and Validation batches
- Drive and manage Non-Conformances, CAPA and Change Controls relative to Tech Transfer activities.
QUALIFICATIONS & EXPERIENCE REQUIRED
- Master’s degree in Life Sciences, Bioengineering, or equivalent
- At least 3 years of experience in pharmaceutical, biotechnology or IVD medical device industry within GMP environment
- Relevant experience in technology transfer processes, bioprocess development or manufacturing technical support
- Knowledge in IVD manufacturing and / or medical devices
- IT skills (PLC, MES, ERP, Access)
- Ability to handle high pressure and tight deadlines
- Flexible, pro-active and team player
- Effective communication skills at all organizational levels and with international cultural sensitivity
- Fluent in French and English
This position may require potential travel to the UK (approximately 1 to 2 times a year)
No recruitment agencies please