You oversee the drug substance manufacturing process, ensuring quality control and compliance. Your responsibilities include monitoring critical variables, supporting product transfers, and contributing to registration activities throughout the product lifecycle.
Anforderungen
- •MSc. in Biotechnology or related field
- •Minimum 5 years of GMP manufacturing experience
- •Process understanding of up- and downstream technologies
- •Experience in computerized systems and applied statistics
- •Understanding of relevant regulatory requirements
- •Proactivity and can-do 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 quality attributes.
- •Improve control strategies as needed.
- •Monitor critical 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**
**Job Description Summary**
Are you a dynamic and innovative professional seeking an opportunity to make a significant impact in the pharmaceutical industry?
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 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.
**Skills Desired**
Communication, Control Strategy, Good Manufacturing Practices (GMP), Manufacturing Processes, Problem Solving, Process Knowledge, Process Understanding