Senior Product Steward (f/m/d)

Sep 07, 2021

Job Description

Senior Product Steward (f/m/d), Novartis Technical Operations, Schaftenau/Kundl, Austria

10 days! That is how long we treat a patient’s T-cells, before we return them to potentially save this patient’s life. To support such novel, personalized treatment is a unique challenge within Novartis with immediate patient impact.

The Senior Product Steward is responsible for the process knowledge of the Cell and Gene Therapy critical starting materials product(s), to support throughout the late-stage clinical manufacturing of Cell & Gene therapy product. , launch and commercial lifecycle. You will maintains the oversight on process capability, through data trending and statistical analysis, ensuring process(es) are robust, comparable, in compliance to cGMPs, in continued state of validation and continuously improving.

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Responsible to maintain and improve the scientific knowledge and oversight of the manufacturing processes and technical changes and capabilities at the Site and to ensure the product and technical stewardship, across process units and functions
• Lead technology transfer activities at site level including any scale-up or other process adaptations
• Track CPV parameters from production, QC, and control systems using statistical analysis and conducting regular product specific data trending
• Initiate and support investigations and improvement projects (quality, efficiency), involving cross-functional teams
• Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters
• Provide all necessary information to perform the validation documentation, align with stability specialist and QC labs to organize the stability samples
• Supports Validation Lead and Experts to assess need and plan validations / re-validations / verifications, consulting approving and reviewing the process validation master plan, together with the Validation Lead or Validation Professionals.
• Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s)

Minimum Requirements

What you’ll bring to the role:
• MSc or PhD in Cellular Biology, Molecular Biology, Immunology, Biotechnology or Biochemical Engineering
• Minimum 5 years of experience in development or manufacturing of gene therapy products, or cell culture products
• Solid understanding of pharmaceutical cGMP production
• Fluent in English and site local language

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities 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 € 63.388,92/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 work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

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:
Novartis Technical Operations
Technical Operations
Full Time
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Senior Product Steward (f/m/d)

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