You oversee the drug substance manufacturing process, ensuring quality control and compliance while facilitating product transfers and validation activities throughout the product lifecycle.
Anforderungen
- •MSc. in Biotechnology or related field
- •Minimum 5 years in GMP manufacturing
- •Process understanding of up- and downstream technologies
- •Experience in computerized systems and applied statistics
- •Understanding of regulatory requirements like GMPs
- •Proactivity and problem-solving attitude
- •Fluent in English, German beneficial
Deine Aufgaben
- •Oversee the entire drug substance manufacturing process.
- •Act as the single point of contact for manufacturing.
- •Support process control strategies based on critical attributes.
- •Monitor key variables using statistical analysis.
- •Conduct regular product-specific data trending.
- •Provide data for product transfer technical activities.
- •Assist in defining necessary studies for product transfer.
- •Support troubleshooting and root cause investigations.
- •Implement corrective and preventive actions (CAPAs).
- •Assist in planning process validations and re-validations.
- •Contribute to registration strategy and activities.
- •Support site inspections during product lifecycle.
Original Beschreibung
# Product Steward, Manufacturing Sciences & Technology (f/m/d), DS Schaftenau, Tyrol, Austria
**Schaftenau** | **Full time**
**Band**
Level 4
**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**
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!
**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**
Communication, Control Strategy, Good Manufacturing Practices (GMP), Manufacturing Processes, Problem Solving, Process Knowledge, Process Understanding