Major Accountabilities:

• Maintain the oversight and knowledge for entire drug substance 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.
• Provide the necessary data for the technical activities involved in transferring a product, including definition of needed studies.
• 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.

Role 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.
• Shown process understanding of up- and downstream technologies (cell culture cultivation, chromatographic separation, filtration, etc.)
• Detailed experience in computerized systems and fundamental understanding of applied statistics (MS-office, SAP, Minitab, JMP, etc.)
• Understanding and oversight of relevant regulatory requirements, e.g. GMPs, ICH Q-guidelines.
• Proactivity and a can-do attitude towards problem solving.
• Fluent in English, German beneficial.

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: http://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. http://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 € 65.605,54  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: http://talentnetwork.novartis.com/network