Senior Expert - Analytical Operations(m/w/x)

# Senior Expert - Analytical Operations **Schaftenau** | **Full time** **Band** Level 4 **Job Description Summary** 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 troubleshooting existing methods, processes, or solving problems of higher complexity within projects * **Role Requirements :** * Master Degree in biotechnology, biochemical engineering, biology, chemistry, biochemistry or similar with at least 4 years strong relevant industry experience or PhD in relevant field or equivalent and 2+ years of work experience within the pharmaceutical industry * Proficiency in English and German is beneficial * Good knowledge of sound technical & scientific of pharmaceutical, chemical analytics, QC or equivalent * Proven experience within GMP environment * Good theoretical and scientific knowledge in the area of expertise (like HPLC, CE) * **Desirable:** * A personality with a can-do mind-set and the ability to adopt to change with strong communication across organizational interfaces and presentation skills * Ability to work and lead (a cross-functional team) in a matrix **Skills Desired** Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model