Method Expert Analytical Sciences (m/f/d) (80-100%)

Your key responsibilities 

As Method Expert you will be part of the Method Expert Team of Process Analytical Sciences at our Biologics site in Austria 
Your responsibilities include, but are not limited to: 

• Method Development and Optimization using QbD Principles: Applying QbD principles, drive and execute the physicochemical analytical (PCA) method development and optimization of assigned pipeline projects for all relevant sample matrices (DS, Drug, DP, Intermediates). Design experiments, perform risk assessments, and utilize statistical tools to develop robust and reliable analytical methods. 

• Method trending: Ensure appropriate trending of method performance parameters by establishing trend/control charts for relevant methods. 

• Advanced Instrumentation and Technology: Leverage advanced analytical instrumentation and emerging technologies to enhance existing analytical methods. 

• Miniaturization and Automation: Explore opportunities for miniaturization and automation to increase throughput, reduce sample and reagent consumption, and enhance efficiency. Implement automated platforms to streamline method development. 

• Data-Driven Approaches: Utilize data analytics, machine learning, and artificial intelligence to analyze large datasets and develop data-driven approaches for method development. Identify critical quality attributes, process parameters and correlations to optimize method performance. 

• Regulatory Compliance: Ensure compliance with regulatory requirements and support filings applying principles described in recent guidelines for analytical method development (e.g. ICH Q2(R2) and Q14). Stay updated on evolving regulatory expectations e.g. related to validation strategies. 

• Collaboration: Collaborate with cross-functional teams, including research, DS & DP process development, quality assurance, and regulatory affairs, to align method development activities with organizational goals and project timelines. Provide technical leadership, guidance, and mentorship to junior team members. 

What you’ll bring to the role  

• Hands-on experience with state-of-the-art analytical instrumentation (HPLC/UPLC, CE, cIEF) 

• Expertise in physicochemical analytical method development 

• Expertise in applying QbD principles 

• Expertise in automation and data & digital  

• Sound technical and scientific knowledge of pharmaceutical development, analytical sciences, or equivalent 

• Experience in biotechnological Chemical Manufacturing Control (CMC) development 

• Ability to work in a matrix environment 

• Influencing without authority 

Desirable requirements 

• University degree in life sciences with practical experience in PCA (e.g. Biotechnology, Chemistry, Pharmacy) 

• Minimum of 2 years of proven experience in the pharmaceutical industry 
 
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 €55,610.59/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 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. 
 
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