Job Description

Essential Functions

• Responsible for contributing to the design of and development execution under moderate supervision.
• Executes assigned tasks and activities to support assay/method development.
• Contributes to technical discussions, experimental design, data review, and sponsor inquiries.
• Assists in troubleshooting and process improvements to increase data quality, lower costs, or reduce turnaround times.
• Presents assay development results in support of data review and transfer to Validation or Production lab.
• Works collaboratively with cross functional stakeholders to facilitate the assay development process.
• Assists in the preparation of technical reports, summaries, protocols, and quantitative analyses.
• Maintains laboratory notebooks under applicable regulatory standards and good documentation practices.
• Follows all appropriate lab and company SOP\'s.
• Participates in continuing education through self-study, attending training sessions and lectures and meetings.
• Responsible for the production of quality data and documentation in adherence to timelines in accordance with regulatory requirements.
• Support safety and 6S requirements and initiatives.

Qualifications

• Bachelor\'s Degree Bachelor\'s degree in relevant scientific discipline (Some CAP/CLIA lab locations may require a BS in chemistry, biology, or medical laboratory technology degree) Req
• 1 year of related experience in method or assay development or specific methodology area.
• Basic knowledge of assay/method development and/or assigned methodology principles, theories, concepts, and instrumentation, typically obtained through advanced education.
• Understanding of sample handling and preparation.
• Proficiency with relevant laboratory techniques.
• Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling.
• General awareness of the broader drug development process and the interaction of method development in that process.
• Ability to troubleshoot laboratory equipment and resolve process issues.
• Basic understanding of requirements under relevant regulatory standards for assigned work area.
• Good computer skills including proficiency with Microsoft Excel, PowerPoint and Word.
• Capable of handling multiple tasks simultaneously.
• Strong attention to detail and accuracy.
• Effective organizational and interpersonal skills.
• Effective communication and presentation skills.
• Ability to work closely with other members of the laboratory.
• Ability to maintain a minor degree of independence to complete assigned tasks and projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Vos principales responsabilit\xc3\xa9s :

• Connaissances en diff\xc3\xa9rents types d\xe2\x80\x99essais qui vont de la pr\xc3\xa9paration des \xc3\xa9chantillons, les tests au labo \xc3\xa0 l\xe2\x80\x99analyse de donn\xc3\xa9es.
• Planifier et ex\xc3\xa9cuter les exp\xc3\xa9riences de laboratoire en suivant les instructions (PON)
• Participer au d\xc3\xa9veloppement des essais selon les requis des clients, incluant les phases de qualification et validation
• Consigner les r\xc3\xa9sultats dans des cahiers de laboratoire selon les SOPs \xc3\xa9tablies ;
• Faire le suivi et maintenir l\xe2\x80\x99inventaire des r\xc3\xa9actifs et mat\xc3\xa9riels ;
• Suivre les proc\xc3\xa9dures en place afin de maintenir la qualit\xc3\xa9 et l\xe2\x80\x99int\xc3\xa9grit\xc3\xa9 des r\xc3\xa9sultats
• Analyser les r\xc3\xa9sultats obtenus et les synth\xc3\xa9tiser au besoin
• Effectuer l\xe2\x80\x99entretien et la calibration des instruments lorsque n\xc3\xa9cessaire
• Participer proactivement \xc3\xa0 toutes initiatives permettant l\xe2\x80\x99optimisation des op\xc3\xa9rations, la satisfaction de nos clients et la croissance de l\xe2\x80\x99entreprise

Ce que nous recherchons :

• Exp\xc3\xa9rience pertinente dans le d\xc3\xa9veloppement, la qualification, la validation et la r\xc3\xa9solution de probl\xc3\xa8mes, en lien avec les analyses en immunologie
• Au minimum un bac en sciences biologiques avec de l\'exp\xc3\xa9rience en techniques immunologiques
• \xc3\x8atre \xc3\xa0 l\xe2\x80\x99aise dans des environnements \xc3\xa0 forte croissance
• Connaissance des bonnes pratiques de laboratoire clinique BPLC est un atout
• Exp\xc3\xa9rience dans un environnement r\xc3\xa9glement\xc3\xa9 (BPL, BPLC)
• Aptitude pour le travail minutieux, la communication et le travail en \xc3\xa9quipe dans un environnement multidisciplinaire;
• Exp\xc3\xa9rience en industrie (CRO, Biopharma ou entreprises en biotechnologies) est un atout
• Dext\xc3\xa9rit\xc3\xa9 manuelle
• Bonne ma\xc3\xaetrise du fran\xc3\xa7ais;
• Connaissances suffisantes de l\xe2\x80\x99anglais \xc3\xa9crit et parl\xc3\xa9 afin d\xe2\x80\x99\xc3\xaatre en mesure de bien comprendre les documents servant \xc3\xa0 l\xe2\x80\x99ex\xc3\xa9cution du travail et d\xe2\x80\x99interagir avec nos clients majoritairement anglophones

Q\xc2\xb2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

IQVIA