Lonza
USP Process Expert MSAT Microbial (m/f/d) - 80% - 100%
The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
We are looking for a: USP Process Expert MSAT Microbial (m/f/d) - 80% - 100%
What you will get:
An agile career and a dynamic work culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below.
Benefits in Visp: https://bit.ly/3wjkoFi
What you will do:
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.
What we are looking for:
Master's degree, PhD or equivalent experience is a plus
Preferred area of study: Biotechnology, chemical engineering or related subject areas
More than 5 years of experience in the area of biopharma manufacturing and / or process development preferable in the area of Microbial Manufacturing
Solid understanding and experience with fermentation processes and primary recovery unit operations
GMP and deep understanding of bioprocess technology
Fluency in English and German
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
Problem-solving
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.