Senior Expert - Analytical Operations

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
• Why Novartis?

• Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
  You’ll receive:
  You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
  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 € 64 023,54 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.
  We are open for part-time and job-sharing models and support flexible and remote working where possible.
  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 [email protected] 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.
  Join our Novartis Network:
  If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

 

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