Société : Stilla Technologies Lieu : Val-de-Marne (Île-de-France)
Présentation de l'entreprise
Stilla Technologies is a European Life Science company based in Paris whose aim is to empower scientists with pioneering digital PCR solutions to build the future of genetic testing. Since 2016, Stilla Technologies is providing research organizations specialized in molecular biology and genetic analysis with its naica™ system, a ground-breaking digital PCR solution that enables scientists to detect and quantify DNA mutations with unrivalled precision. With the naica™ system, researchers can build a new generation of high-precision genetic testing in a wide range of applications such as liquid biopsy tests for cancer diagnostics, pre-natal testing, Gene Therapy, infectious disease or GMO detection. After the completion of a Series B funding of 20 MEUR, the US subsidiary Stilla Technologies Inc. is looking to accelerate the sales of the naica™ system in the Americas, develop a 3rd generation of its digital PCR solution, and launch clinical validations of diagnostics tests to be run on the system with an initial focus in the field of oncology, gene therapy, infectious diseases, and general QC testing. Stilla launched their U.S. subsidiary in 2019 to enable direct commercial operations and customer support in the Americas. The new U.S. headquarters in Beverly, Massachusetts is run by Ruth Szebries and includes a demo lab and training center for American customers. Please read our latest PR at https://www.illuminaventures.com/spotlight-stilla-november-2019.
Our multi-disciplinary team in microfluidics, mechanical engineering, biology, and software shares a passion for building successful Life Science Products based on deep technological innovation. We are pursuing a huge potential market on which we have the potential become the new leader.
Descriptif du poste
Société : Stilla Technologies Catégorie : Offre emploi CDI Activité : Services aux entreprises Filiere : Etudes, Recherche, Projet Metier : Industrialisation / Engeenering Lieu : Val-de-Marne (Île-de-France)
Mission
In the Transfert and Outsourced Product-LCM team, she/he is in charge of the transfer and industrialization validation of new products and new processes of Stilla Technologies.
She/he is working with external partners and with QC, R&D and/or Production teams, in order to:
Manage the Industrialization of new Stilla products:
- Requirement definition for Industrialization part
- Selection of providers
- Oversee of development steps and/or external industrialization steps (Improvement of product, qualification IQC/FQC and implementation of new methods or material, prototypes or pilot lots validation, help in IQ/OQ/PQ process)
- Quality documentation for the product/process
- Scheduling and organization of required studies (stability, CEM, ISTA,...) with the aim of description of performances and regulatory folder completion
- Discussions around and implementation of Supply and quality agreements
- Technical survey for PCR technologies and associated process
- Support quality audits
Be the technical reference to ensure the continuous improvement:
- After customer complaint, Unconformity or other internal event, Management of continuous improvement of Stilla products
- Troubleshooting of technical and/or process issues
- Technical contact for the suppliers to solve the quality issues
Promote the results by:
- Data presentation (reports, PPT presentations, Instructions, ...)
- Data registration for grantable results and ideas
Manage a project team and transversal teams:
- Project coordination during industrialization steps, with the management of all teams, including R&D, Ops, Marketing/Sales, Quality and external teams
- Carrying out technical operations
- Efficient relationship between teams
- Project management according to all procedures in force (QMS, V cycle, Agile method, ...).
Profil recherché
- Master 2, Industrialization Engineer, Biomolecular PhD, Biomedical PhD or Biochemical PhD,
- Good technical expertise in Molecular Biology, ideally dPCR or qPCR and/or medical automates and fluorescence imagery
- With at least 2 years of experience in development or industrialization of IVD tests or biomedical machines
- Expertise in data analysis, in scheduling tools and Microsoft suite for reports, presentations, ...
- Good knowledge of quality and regulatory standards in DM-DIV (ISO 13485, IVDD/IVDR, ISO23640, ...)
- French and English fluently
- Ability to manage teams and to negotiate with subcontractors, support quality audits
- Autonomous, organized and proactive, the she/he loves a challenge and shows intellectual curiosity with a strong team spirit and initiatives. CLIQUER ICI POUR POSTULER
