Product Steward Lead, Manufacturing Sciences & Technology(m/w/x)

Product Steward Lead, Manufacturing Sciences & Technology (f/m/d), DP Schaftenau, Tyrol, Austria

Schaftenau | Full time

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 Lead. 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. Additionally, you will lead a talented team of 8 people, ensuring they are well-equipped and motivated to achieve their goals, fostering a collaborative and productive work environment.

Job Description

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Lead the team of Product and Technical Stewards in MS&T , DP Schaftenau

• 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).

• 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 during life cycle of the product as well as site inspections

What you’ll bring to the role:

• MSc. in Biotechnology, Chemistry, Pharmacy, Chemical Engineering. Minimum 7 years of experience in GMP manufacturing relevant and/or late stage development to the specialist area of expertise and/or QA/QC.

• Leadership experience in leading teams (direct reporting lines) and working in a matrix organization Consistent record in leading interdisciplinary teams, project management skills as well as good communication skills.

• Understanding and oversight of relevant regulatory requirements, e.g. GMPs, ICH Q-guidelines.

• Ability to act in a sophisticated and rapidly changing business environment.

• Proactivity and a can-do attitude towards problem solving.

• Fluency in English.

• Shown process understanding of aseptic processes is desirable.

• 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!

You’ll receive:

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 € 77.543,90 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.

Skills Desired

Applied Statistics, Applied Statistics, Assembly Language, Back-End Development, Biotechnology, Chemical Engineering, Chemistry, Design Development, Electronic Components, General Hse Knowledge  , Incentive Program, Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Leadership, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Npd (New Product Development), Process and Cleaning Validation, Process Control, R&D (Research And Development), Root Cause Analysis (RCA), Software Development, Software Engineering {+ 1 more}