Novartis
pharmaceutical
SeniorExpertAnalyticalOperations(m/f/d)
“Senior Expert - Analytical Operations (m/f/d) at Novartis. Skills: Analytical Operations, Biologic drugs development, method validation, method transfer. 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)”
What You'll Achieve.
releasing the product for clinical trial; investigating the stability behavior of the drugs; validating the methods used for release; transferring the methods to our commercial organization or external partners
Industry & Context.
investigating quality events; deviations; changes; out-of-specifications events; troubleshooting existing methods; processes; solving problems of higher complexity
working in a hybrid environment both in and out of the lab delivery of GMP products
What They're Looking For.
Must Have
Master Degree in biotechnology, biochemical engineering, biology, chemistry, biochemistry or similar with at least 4 years relevant industry experience or PhD in relevant field or equivalent and 2+ years of work experience within the pharmaceutical industry, Proven experience within GMP environment, Good theoretical and scientific knowledge in the area of expertise (like HPLC, CE)
Nice to Have
A personality with a can-do mind-set and the ability to adopt to change with communication across organizational interfaces and presentation skills, Ability to work and lead (a cross-functional team) in a matrix
What You'll Do.
Independently managing key tasks for projects (e.
release, stability studies, validation, and transfer activities), Writing protocols, scientific reports, lab procedures and providing ready-to-submit documents intended for submissions (e.
release or stability documents, transfer reports), Approving GMP documents and test records as well as investigating quality events within the project (e.
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.
How You'll Work.
Team & Collaboration
communication across organizational interfaces; work and lead (a cross-functional team) in a matrix
Communication Scope
communication across organizational interfaces; presentation skills
Process & Methodology
Independently managing key tasks for projects
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