MSAT Bio DS Process Lead

vor 2 Wochen

Bulle FR, Freiburg, Schweiz UCB S.A. Vollzeit

Make your mark for patients

We are looking for an MSAT Bio DS Process Lead who is eager to join us in our Internal & External Manufacturing Large Molecules MSAT, based in our manufacturing site in Bulle, Switzerland.

About the role

As an MSAT Bio DS Process Lead, you will drive process Tech Transfers and support commercial-scale process validation for microbial biotechnological manufacturing processes. You will manage process documentation, provide routine support for manufacturing campaigns, and troubleshoot for CMOs. Additionally, you will support Health Authority inspections, monitor manufacturing for improvements, and coordinate small-scale testing and process improvements. Liaising with development teams, you will provide feedback on process performance and request second-generation process development as needed.

What you'll do

  • Support commercial-scale process validation and drive process Tech Transfers and changes for microbial biotechnological manufacturing processes, between commercial plants and new plants.
  • Provide routine support for manufacturing campaigns, CPV, equipment performance, troubleshooting, Health Authority inspections, and process improvements within approved parameters.
  • Act as the primary contact for regulatory partners, development teams, and Industrial Leads post-Tech Transfer, internalize development history, and manage process documentation for approved/commercial processes.
  • Provide expertise in development studies, PCS reports, and product history, participate in product TST meetings, and support the MSAT Tech Transfer & Validation Manager with documentation review and Health Authority inspections.
  • Lead process validation activities for microbial biotechnological manufacturing processes, including risk assessments, change controls, validation plans, protocols, and adherence to applicable documents.
  • Implement and coordinate Continued Process Verification (CPV) for new processes, including initial and routine CPV plans, process data trending, complex investigations, and coordination with CMOs/partners.
  • Drive continuous improvement of Tech Transfer, process validation, and CPV, including monitoring manufacturing and implementing process improvements.
  • Collaborate across teams to provide process expertise, lead improvement projects, and support deviations and Change Controls.

Interested? For this role we're looking for the following education, experience and skills

  • Master's in biology/biotechnology/life sciences.
  • Proven experience in biotech industry. High understanding of biotechnological manufacturing processes.
  • Strong leadership skills.
  • Basic knowledge of statistics.
  • Excellent communication skills, for communicating with internal and external partners.
  • Ability to scope, research and understand complex subjects related to biotech manufacturing.
  • Ability to structure ideas quickly and clearly.
  • Excellent organization and problem-solving skills.
  • Ability to define objectives and how to reach them.
  • High capacity to anticipate issues, identify priorities and make decisions.
  • High level of autonomy and good stress management skills.
  • Solution-oriented and sensitive to customer needs.
  • Pragmatic and critical-minded.
  • Sense of responsibility, ownership, and initiative.
  • Team player.
  • Excellent level of English and French (both written and verbal).

Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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