We are Recruiting on a long term temporary contract, an experienced Senior Scientist with expertise in HPLC analysis for biological products.
Join us at Modis to participate to the development of innovative therapies!
As a part of the QC the Senior Scientist has the responsibility of the release analytics for a broad range of analytical methods regarding biopharmaceutical molecules. (Usage for clinical and commercial purposes).
· Coordination of projects and taking care for the technical realization of project steps during method transfer and consulting on projects after method transfer
· Reporting on project progress and the escalation of issues when they occur
· Initiation and completion of necessary process change controls, deviation and laboratory investigation reports
· Responsible for providing and organizing adequate training to QC associates in order to enhance the site level compliance cGMP knowledge
· Proactive follow-up on development activities within the applicable discipline as well building up and sharing of knowledge within the QC department
· Creation, revision and review of cGMP documentation (SOP’s, Quality Instructions, protocols, reports…) based on a standard format related to quality control activities.
Participate in project related audits if applicable
· PhD degree in chemistry, biochemistry or equivalent education; or experienced professional with a Bachelor or Master Degree in a scientific discipline
· Expert scientific knowledge in the field of analytical chemistry, focus HPLC
· Versed with regulations (GMP & ISO 9001)
· Languages: Good English skills, German beneficial
· IT skills: Software use in OC like LIMS, Empower, DMS etc.
· Good communication skills, ability to work independently and a deep sense of responsibility