Product Steward (m/f/d) Schaftenau, Tirol, Austria

Job Description Summary

Are you a dynamic and innovative professional seeking an opportunity to make a significant impact in the pharmaceutical industry?
Join Novartis, a global healthcare leader dedicated to reimagining medicine to improve and extend people’s lives. At Novartis, we believe in creating a culture of continuous learning and growth, encouraging our employees to push boundaries and achieve their full potential.
We are currently seeking a passionate and skilled individual for the role of Product Steward. In this critical position, you will own the process knowledge of our products throughout their commercial lifecycle, ensuring continuously improving processes. Your expertise will be vital in maintaining seamless knowledge flow across functions and sites, providing technical and scientific process support.
If you are ready to bring your expertise and enthusiasm to a company that values innovation and excellence, we invite you to explore the exciting opportunities at Novartis. Join us in our mission to transform the future of healthcare.

 

Job Description

Your responsibilities include, but are not limited to:

• Maintain the oversight and knowledge for entire drug product manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as single point of contact (SPOC).
• Support an appropriate process control strategy based on critical quality attributes (CQA) and on critical process parameter (CPP), critical material attributes (CMA) and support improving the control strategy where applicable. Create and maintain a product specific Quality Risk Analysis (QRAs).
• Monitor and evaluate all critical and key variables as appropriate using statistical analysis and conduction regular product specific data trending (e.g. ongoing process verification OPV, APQR) and communicate at site level.
• Present process performance and status of product improvement projects in site and global Manufacturing Robustness Review Board (MRRB).
• Lead root cause investigations and evaluate potential impact of deviations on final product quality and patient safety using root cause investigation tools and establish appropriate corrective actions and preventive actions (CAPAs)
• Supports Validation Lead and Process Experts to assess and plan process validations and assess re-validation needs.
• Contribute to registration strategy and support registration activities during life cycle of the product

Essential Requirements:

• MSc. in Biotechnology, Chemistry, Pharmacy, Chemical Engineering.
• Minimum 5 years’ of experience in GMP manufacturing relevant and/or late stage development to the specialist area of expertise and/or QA/QC.
• Basic understanding of relevant regulatory requirements, e.g. GMPs, ICH Q-guidelines.
• Shown process understanding of aseptic processes is desirable
• Consistent record in leading interdisciplinary teams, project management skills as well as good communication skills.
• Ability to act in a sophisticated and rapidly changing business environment.
• Proactivity and a can-do attitude towards problem solving. Knowledge in troubleshooting tools is a plus
• Fluent in English, German is a plus
• Extensive experience with computerized systems, solid experience in handling data and basic understanding of applied statistics (e.g. MS Office, SAP, Minitab, JMP)

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). In most cases, the actual salary will be 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: :

We are committed to building an outstanding, inclusive work 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

 

Skills Desired

Applied Statistics, Assembly Language, Change Control, Chemical Engineering, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge  , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Process Simulation, Risk Management, Root Cause Analysis (RCA), Scientific Method, Six Sigma, Statistical Analysis, Technology Transfer