Senior Expert - Analytical Operations (m/f/d)

Job description

Job Description Summary Location: Schaftenau, Austria #onsite Role Purpose: As a Senior Expert you will be part of a team developing new Biologic drugs. Analytical Operations is the team releasing the product for clinical trial and investigating the stability behavior of the drugs. Furthermore, we are validating the methods used for release and will be also responsible for transferring the methods to our commercial organization or external partners. The role will be a mix of overseeing development and authoring/completing documentation. As such, you should be comfortable working in a hybrid environment both in and out of the lab delivery of GMP products. Job Description: Major Accountabilities: Independently managing key tasks for projects (e.g. release, stability studies, validation, and transfer activities) Writing protocols, scientific reports, lab procedures and providing ready-to-submit documents intended for submissions (e.g. release or stability documents, transfer reports) Approving GMP documents and test records as well as investigating quality events within the project (e.g. deviations, changes, out-of-specifications events). Supporting the lab team in case of troubleshoo...