Product Steward (f/m/d)

Aug 19, 2021

Job Description

Product Steward (f/m/d), MS&T, Schaftenau, Austria

799 million. That’s how many lives our products touched in 2019.
Join our team as Product Steward (f/m/d) and you can make a difference to millions of patients around the world by pioneering technological innovation, supporting the life cycle management and continuously improvement of one of the most diverse and innovative product & manufacturing portfolios within the Large Molecule division.

Your key responsibilities:

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.
• 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)
• Assess impact of process and technical changes, assess their technical feasibility and determine scope of technical batches, challenge technical and process risk and business benefit of process/technical changes proposed
• Ensures seamless flow of knowledge and information within department, across site functions, and with other Sites when applicable, with focus on the assigned product(s)
• Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed
• Supports Process Experts in trouble shooting / root cause investigations / implementation of 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

Minimum Requirements

What you’ll bring to the role:
• BSc. in Biotechnology, Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology. Desirable MSc in the above or equivalent
• Minimum 6 years’ of experience in GMP manufacturing relevant and/or late stage development to the specialist area of expertise and/or QA/QC
• Shown process understanding of compounding, sterile filling and visual inspection technologies
• Detailed experience in computerized systems and fundamental understanding of applied statistics (MS-office, SAP, Minitab, etc.)
• Understanding and oversight of relevant regulatory requirements, e.g. GMPs, ICH Q-guidelines.
• Fluent in English, German beneficial
• Ability to act in a sophisticated and rapidly changing business environment
• Consistent record in leading interdisciplinary teams, project management skills as well as communication skills

Desirable requirements:
• Great teammate with ability to foster stakeholder engagement
• Strong negotiator, influencing and persuading

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 € 52,204.04 /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:
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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Product Steward (f/m/d)

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