Salary Range:
€66,918.00 - €112,600.00

Band
Level 4

Job Description Summary
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.

Job Description

Major accountabilities:
- Maintain oversight and end-to-end process knowledge of the drug substance manufacturing process across the entire commercial lifecycle, acting as the single point of contact (SPOC) from technology transfer through commercialization.
- Support the development, maintenance, and continuous improvement of the process control strategy, based on Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and Critical Material Attributes (CMAs).




- Monitor and evaluate critical and key process variables through statistical analysis and regular product-specific trending activities (e.g., Ongoing Process Verification (OPV), Annual Product Quality Reviews (APQR)), and communicate insights at site level.
- Provide technical and process data required for product transfer activities, including the definition and execution of necessary studies.
- Support Process Experts in troubleshooting activities, root cause investigations, and the implementation of Corrective and Preventive Actions (CAPAs).
- Support Validation Leads and Process Experts in planning and assessing process validation activities, including evaluation of re-validation requirements.
- Contribute to product registration strategies and support regulatory submissions, lifecycle management activities, and site inspections.

Essential requirements:
- Master’s degree (MSc) in Biotechnology, Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline.
- Minimum 5 years of experie

📌 Product Steward (Yurimaguas)
🏢 DTX Pharma, a Novartis
📍 Yurimaguas