Develop and validate analytical methods to support projects in development in different phases of product development.
Perform analyses of raw materials, intermediate products, in bulk or pakaged finished products in accordance with work instructions and established procedures (stabilities, in-process control, clinical release, investigation, ...).
Ensure stability analyses and clinical release for clinical phases I and II, as well as any analyses in support to process understanding (IPC test, forced degradation study, multimedia dissolution, ...)
Analyze results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
Participate to analytical exercise transfer to QC and subcontractors.
Monitor the documentation associated with the analytical laboratory activities by mastering the computer softwares in use at the laboratory (eg Mikado, GLIMS, e-noval, TrackWise, ...).
Quality :
Make sure to have received and understood all the information and instructions required for the tasks before starting work.
Respects the procedures and reports any discrepancies to the responsible
Use authorized and validated methods prior to testing, if applicable.
Respect and properly maintain the analytical equipment and facilities at disposal.
Performs double check the team
Profil
Master or Bachelor: analytical chemistry
Key technical backgrounds: small molecule chromatography (HPLC/UHPLC/GC) and detection techniques (UV/Vis, MS), USP/EP Pharmacopoeias
Mandatory skills: team player, exp. in a similar position/environment, compliant/rigorous (understands the importance of following procedures in detail)
Offre
Voiture d'entreprise
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.