Engineer, Qc Methods for Reagent Development
Il y a 4 mois
**DNA Script**
Our clean, efficient Enzymatic DNA Synthesis (EDS) technology, implemented on a benchtop instrument (the SYNTAX), accelerates innovation in life science and biotechnology through the decentralization of rapid, on demand and high quality DNA synthesis.
Our approach builds upon nature's billions of years of evolution in enzymatically synthesizing DNA, setting new standards for assembling nucleic acids to accelerate scientific discovery and DNA/RNA production in disciplines with profound impacts upon humanity.
DNA Script has a broad stable of high quality investors and is capitalized to continue its progress to full commercialization of the technology and products. We are building an organization across our two sites, in Paris and San Francisco, with the talent, skills and attitude to achieve our mission: to unlock the power of "DNA-write".
This is an opportunity for a dynamic individual to join an international and highly skilled team, and to make significant contributions to commercializing a technology with far-reaching potential across the biological sciences and beyond.
**Rôle**
**Missions principales**
- Définir, développer, optimiser et mettre en place les nouvelles méthodes et les méthodes existantes de test de contrôle qualité (QC) des réactifs (tampons, enzymes, nucléotides), consommables et kits : déterminer les seuils pertinents, les critères d'acceptation, la linéarité, la limite de détection (LOD), la limite de quantification (LOQ), la répétabilité et reproductibilité ;
- Établir les spécifications et les tests analytiques et fonctionnels nécessaires pour qualifier les matières premières et les produits finis ;
- Participer à l'établissement des design expérimentaux pour un transfert efficace vers l'équipe QC ;
- Communiquer efficacement avec les départements R&D, développement de produits (PD) et QC pour traduire les méthodes de test et de contrôle ébauchées en R&D en instructions de méthodes QC validées sur des équipements analytiques ;
- Participer à la rédaction des protocoles et rapports de transfert et validation afin d'assurer la traçabilité des process développés et faciliter les transferts et la formation de l'équipe QC ;
- Former l'équipe QC aux nouvelles méthodes de test développées ;
- Comprendre et implémenter les process de qualité comme Change Control, Corrective Actions/Preventative Actions (CAPA), Risk Analysis et Out of Specification (OOS) ;
- Être garant des bonnes pratiques de laboratoire/documentation, rédiger des procédures opérationnelles standard (SOP) et les faire appliquer ;
- Présenter régulièrement l'avancement de vos travaux au sein des départements R&D, PD, et QC ;
- Promouvoir l'amélioration continue dans l'entreprise, en dehors de son domaine d'expertise immédiat lorsque cela est nécessaire, afin de garantir la robustesse des processus de méthodes QC des réactifs.
**Expérience demandée**
- Bac+5 en Biotechnologie, Biologie Moléculaire, Chimie, ou équivalent
- 1 à 3 ans d'expérience en R&D et/ou Contrôle Qualité
- Expérience dans les méthodes analytiques de biologie moléculaire, biochimie et chimie (qPCR, caractérisation et/ou synthèse d'acides nucléiques, test d'activité, électrophorèse, HPLC).
- Bonne connaissance en CQ/AQ
- Intérêt pour le travail sur automates
- Bonne maîtrise d'Excel
- Grande rigueur et qualité d'organisation
- Dynamisme, réactivité et adaptabilité (capable de gérer des changements de priorités)
- Aptitude à travailler au sein d'une équipe multidisciplinaire
- Excellentes compétences en communication et relations interpersonnelles
- Bon niveau d'anglais (équipe internationale)
**Souhaitée**
- Connaissances en statistiques
- Expérience dans le développent de protocoles DOE
- Capacité à interpréter et manipuler des données Next Generation Sequencing (NGS)
- Expérience dans une société de biotechnologie et/ou dans un environnement de production/haut-débit avec des systèmes d'automatisation et/ou en environnement GMP
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