MSAT - Process Expert

Real; Oberwallis; On-site; CHF 120,000 - 160,000; Full time

Job summary

Real is seeking a highly experienced MSAT Process Expert in Visp, Switzerland to lead mammalian cell culture DSP/USP processes. The role focuses on technology transfer, scale-up, smooth operation, and continuous improvement within a GMP environment.

You will coordinate cross-functional teams, interface with process development and operations, and contribute to capital projects for building and commissioning manufacturing units. Fluency in English and strong leadership are essential for success.

Qualifications

• Preferred area of study: Biotechnology, chemical engineering or related disciplines.
• More than 5 years of experience in biopharma manufacturing and / or process development preferable in the area of Mammalian Manufacturing.
• GMP and deep understanding of bioprocess technology.
• Fluency in English.
• Strong leadership skills.
• Very good communication skills and interaction with all kinds of interfaces within customers and the project organisation.
• Strong team orientation.
• Structured, focused and well-organized working attitude.
• Open-minded for new ideas and suggestions.
• Agile, highly motivated and dynamic drive.

Responsibilities

• Leading cross functional teams as a process expert tasked with technology transfers (process design and up-scaling) and timely process implementation at manufacturing scale.
• Act as the interface between the process donor (customer, process development) and operations.
• Securing success during technology transfer by applying formal processes and tools to manage the transfer of information, process related risks and change control
• Working as MSAT process expert in Capital investment projects for building and commissioning of the manufacturing units.
• Responsible for implementing the manufacturing process in the plant.
• Interacting directly with customers during tech transfer, campaign preparation, execution and closure including daily reporting of batch status and performance.
• 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.
• Responsible for continuous improvement of process performance
• Supervising tasks in the area of local and global MSAT initiatives or leading major task forces or troubleshooting teams.
• Evaluating and driving innovative trends within the respective area of expertise
• Acting as a mentor for scientific and production staff in different fields of expertise.
• Performing process specific trainings for production staff.
• 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.

Skills

Leadership

Cross-functional teams

GMP knowledge

Biopharma manufacturing

Process improvement

English fluency

Education

Biotechnology

Chemical engineering

Tools

MSAT tools

Tech transfer processes

Job description

MSAT - Process Expert Mammalian Cell Culture DSP

The site in Visp, Switzerland is growing and for our Biologics organization, we are currently looking for experienced Process Experts in Ibex® Solutions, our recently launched unique biological manufacturing and development concept. We have opportunities in both USP and DSP in Drug Substance for mammalian large-scale manufacturing (up to 20.000L). As a process owner, you are responsible for the successful scale up, supervision and optimization of mammalian processes.

Key Responsibilities

• Leading cross functional teams as a process expert tasked with technology transfers (process design and up-scaling) and timely process implementation at manufacturing scale. This includes the whole lifecycle of assigned projects from planning over coordination, implementation, control and project completion aligned with project management goals.
• Act as the interface between the process donor (customer, process development) and operations. Responsible to ensure process scalability and manufacturability.
• Securing success during technology transfer by applying formal processes and tools to manage the transfer of information, process related risks and change control
• Working as MSAT process expert in Capital investment projects for building and commissioning of the manufacturing units. Main responsible for delivering all input required for the specific processes (block-flow diagrams, media and buffer lists, critical parameter lists)
• Responsible for implementing the manufacturing process in the plant.
• Interacting directly with customers during tech transfer, campaign preparation, execution and closure including daily reporting of batch status and performance.
• 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.
• Responsible for continuous improvement of process performance
• Supervising tasks in the area of local and global MSAT initiatives or leading major task forces or troubleshooting teams.
• Evaluating and driving innovative trends within the respective area of expertise
• Acting as a mentor for scientific and production staff in different fields of expertise.
• Performing process specific trainings for production staff.
• 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.

Qualifications

• Preferred area of study: Biotechnology, chemical engineering or related disciplines
• More than 5 years of experience in the area of biopharma manufacturing and / or process development preferable in the area of Mammalian Manufacturing
• GMP and deep understanding of bioprocess technology
• Fluency in English
• Strong leadership skills
• Very good communication skills and interaction with all kinds of interfaces within customers and the project organisation
• Strong team orientation
• Structured, focused and well-organized working attitude
• Open-minded for new ideas and suggestions
• Agile, highly motivated and dynamic drive