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

# Senior Expert – Analytical Operations (m/f/d) **Schaftenau** | **Full time** **Job Description Summary** About the role: # LI-Hybrid 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** **Key responsibilities:** * 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. **Essential Requirements:** * Master’s 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 Requirements:** * A personality with a can-do mindset and the ability to adapt to change with strong communication across organizational interfaces and presentation skills. * Ability to work and lead (a cross-functional team) in a matrix. **You’ll receive:** In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 65,605.54 a year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. **Commitment to Diversity & Inclusion:** Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve. **Adjustments for Applicants with Disabilities** If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV. **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