Analytical Methods Validation Bio
About our client
The new Global Quality (GQC&PQ) organization have the goal to bring innovation, integrated capabilities, and speed to our customers through an empowered team that deliver results and enable network success. Within GQCPQ, the Global Quality & innovation team drives Transversal Innovation through multi-sites feasibility, POC & implementation of new technologies for QC Project is to support the feasibility, fit-for-purpose and business cases of new immunoassays replacing current in-vivo potency for DTaP vaccines.
The missions
1. To develop, design, perform & analyse new immunoassays (ELISA, Luminex)
(Primary skill).
2. Manage the feasibility & fit-for purpose study including, project management,
business case and reporting & communication to different stakeholders (Secondary
skill)
Primary Tasks & Responsibilities
- Manage the feasibility & fit-for-purpose of new immunoassays.
- Perform experimental plan, analyse the results, manage the troubleshooting.
- Manage lab work (training, stock management, data integrity); Work in GMP lab environment.
- Feasibility, fit-for-purpose, and method development design.
- Protocol & report writing.
- Communication of the results
- Project management (stakeholder maping, planification)
Experience, Knowledge & Soft Skill Requirements
Experience
- Demonstrated proficiency one or more of the following areas:
- Immunoassay development, validation (for QC)
- Project management
- Lab activities
- Data analytics (including calculation method)
- Preferably minimum 3 years’ experience in the Pharmaceutical Industry with proven lab activities management of and project management
- Capability of working independently and ability to prioritize tasks and meet strict deadlines.
Knowledge
- The activity requires a broad and thorough knowledge of immunoassays including development, validation and method troubleshooting.
- Strong interest and experience in immunoassay and scientific software development
- Experience in software use (SoftMaxPro, Combistat, PLA, Gen5,…)
- Soft Skills: · Strong problem-solving skills, profound background in scientific analytical method · S/he will be well organized, open-minded, able to work on different projects in parallel, and have a project-orientated spirit. · S/he should have good communication skills in English and an open, proactive personality to work in a team of young international researchers.
Education, Methodology & Certification Requirements
- Master, engineer or Ph.D. in biology, biochemistry or immunology.
- Good knowledge in analytical methods
- ICT Skills (software, operating systems, hardware, etc.)
- Microsoft Windows
- SoftMaxPro, Combistat
- Excel or other soft for data analysis (tab, graph, basic statistic) Familiar with MS Office package
Language Proficiency Requirements
· English Fluent
· French is a plus
Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
