MSAT USP Expert

Proclinical is seeking a dedicated and experienced individual to join the Manufacturing Science & Technology Team in a senior position. The successful candidate will play a crucial role in the transfer, scale-up, overseeing and optimization of biopharma processes. This role requires a deep understanding of process science and manufacturing aspects, and the ability to contribute significantly to the development of the MSAT toolbox.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Oversee the teams in technology transfers and process implementation at manufacturing scale.
• Act as the interface between the process donor and operations, ensuring process scalability and manufacturability.
• Manage the transfer of information, process-related risks, and change control during technology transfer.
• Resolve process issues that may arise during manufacturing, considering all regulatory requirements.
• Execute GMP risk analysis for the manufacturing processes.
• Work as an MSAT process expert in Capital investment projects for building and commissioning of the manufacturing units.
• Implement the manufacturing process in the plant.
• Interact directly with customers during tech transfer, campaign preparation, execution, and closure.
• Compile process-related deviations, change requests, and campaign reports.
• Contribute to the development and implementation of standardized MSAT procedures and processes.
• Supervise tasks in the area of local and global MSAT initiatives or lead major task forces or troubleshooting teams.
• Evaluate and drive innovative trends within the respective area of expertise.
• Act as a mentor for scientific and production staff in different fields of expertise.
• Perform process-specific trainings for production staff.

Key Skills and Requirements:

• PhD or Master's degree in biotechnology, chemical engineering or another relevant field.
• Proven working history in biopharma manufacturing and/or process development.
• Deep understanding of GMP and bioprocess technology.
• Excellent communication skills and ability to interact with various interfaces within customers and the project organization.
• Fluency in English is required and knowledge of German is a plus.

If you are having difficulty in applying or if you have any questions, please contact Saulge Hubert at s.hubert@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.