USP Process Expert MSAT

Lonza

Visp, Switzerland

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 a very experienced professional, you are regarded as a senior 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

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
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
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

Key Requirements

PhD (preferred), Master’s/Master’s degree in biotechnology, chemical engineering or related disciplines
Working experience in biopharma manufacturing and/or process development preferable in of Mammalian Manufacturing
Deep 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

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job