You manage technology transfer and technical risks while ensuring effective communication and compliance in manufacturing processes. Your role includes supporting customers, leading improvements, and mentoring staff across various functions.
Anforderungen
- •PhD, Master's or Bachelor's degree in biotechnology
- •Working experience in biopharma manufacturing
- •Working experience in technology transfer (preferred)
- •Understanding of GMP and bioprocess technology
- •Very good communication skills
- •Fluency in English
Deine Aufgaben
- •Manage technology transfer processes and tools.
- •Oversee technical risks in process transfer.
- •Ensure communication of critical process information.
- •Interface between process donor and operations.
- •Resolve manufacturing process issues and ensure compliance.
- •Execute GMP risk analysis for manufacturing processes.
- •Implement manufacturing processes in the plant.
- •Provide 24/7 technical support and process monitoring.
- •Interact with customers during tech transfer and reporting.
- •Compile process deviations, change requests, and reports.
- •Prepare CMC sections for filing documents.
- •Develop and implement standardized MSAT procedures.
- •Lead technical investigations for process improvements.
- •Identify opportunities for business improvements.
- •Mentor scientific and production staff.
- •Share knowledge and information across teams.
Original Beschreibung
# USP MSAT Process Expert - (80-100%) - (m/f/d)
**CH - Visp** | **Full time**
**Process Expert MSAT (m/f/d)**
As a member of the MSAT (Manufacturing Science & Technology) Team Ibex Visp responsible for the successful transfer, scale up, supervision and optimization of biopharma processes. As an experienced professional, you are regarded as an expert in process science and manufacturing aspects. In this role, you significantly contribute to the development of the MSAT toolbox and share the manufacturing responsibility as a long-term process owner.
**Key Responsibilities**
* Securing success during technology transfer by applying formal processes and tools to manage the transfer of information, process related risks and change control.
* Accountable for the management of technical risks associated with process transfer, identification and introduction of new raw materials and project completion aligned with project management goals.
* Works cross functionally to ensure communication of critical process and technical information to meet the required deadlines / customer outcomes.
* Act as the interface between the process donor (customer, process development) and operations. Responsible to ensure process scalability and manufacturability
* Responsible for the resolution of process issues that may arise during manufacturing, considering all regulatory requirements
* Responsible for execution of GMP risk analysis for the manufacturing processes
* Responsible for implementing the manufacturing process in the plant
* Accountable for independent 24/7 on plant technical support, process monitoring and complex data analysis. Frequency of this task is based on team roster.
* Interacting directly with customers during tech transfer, campaign preparation, execution and closure including daily reporting of batch status and performance. Represents and is an influential MSAT team member within multiple Customer facing projects.
* Ensuring timely compilation of process related deviations, change requests and campaign reports
* Compiling CMC sections in filing documents and technical content of validation reports
* Contributing to the development and implementation of standardized MSAT procedures and processes
* Leads technical investigations to ensure continuous improvements are made to the process and operations.
* Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond. Understand how to efficiently engage others in the change processes.
* Acting as a mentor for scientific and production staff in different fields of expertise
* Generously shares information and knowledge with other across teams and functions. Demonstrates high integrity.
**Key Requirements**
* PhD (preferred), Master’s or Bachelor degree in biotechnology, chemical engineering or related disciplines
* Working experience in biopharma manufacturing and / or process development preferable in of Mammalian Manufacturing
* Working experience in technology transfer for Mammalian Manufacturing (preferred)
* Understanding of GMP and bioprocess technology
* Very good communication skills and interaction with all kinds of interfaces within customers and the project organization
* Fluency in English