MSAT Bio DS Process Specialist

Make your mark for patients

We are looking for an MSAT Bio DS Process Specialist 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 a MSAT Bio DS Process Specialist, you will play a pivotal role in the development and optimization of downstream processes for biologics. Your responsibilities will include ensuring process scalability, troubleshooting production issues, and collaborating with cross-functional teams to enhance process efficiency and product quality.

This position requires a strong understanding of bioprocessing principles and hands-on experience with downstream processing techniques.

What you’ll do

• Support Process Tech Transfers: Facilitate the transfer of microbial biotechnological manufacturing processes from development to internal manufacturing and CMOs, ensuring successful commercial-scale process validation and transitions between commercial plants.
• Support Tech Transfer Activities: write risk assessments and protocols, coordinate sampling and analyses, and ensure adherence to project planning in collaboration with Quality Assurance, Industrial Leads, and other stakeholders.
• Primary Contact for Lifecycle Management: Serve as the main point of contact within the MSAT Tech Transfer & Validation team for regulatory partners, development teams, and Industrial Leads, internalizing development history and managing process documentation for approved/commercial processes.
• Support and Expertise: Provide knowledge on development studies, PCS reports, and product history, participate in product TST meetings, and assist the MSAT Tech Transfer & Validation Manager with documentation review and Health Authority inspections and other stakeholders.
• Process Validation Support: Define validation strategies, conduct risk assessments, write validation plans and reports, and ensure adherence to applicable documents for microbial biotechnological manufacturing processes.
• Continued Process Verification (CPV): Implement CPV for new processes, create CPV plans and reports, lead CPV investigations, and coordinate CPV activities with CMOs/partners.
• Operational Support: Provide routine support for manufacturing campaigns, CPV, equipment performance trending, new equipment or raw material qualification, troubleshooting, periodic reviews, Health Authority inspections, and PAS submissions.
• Continuous Improvement and Monitoring: Participate in the continuous improvement of Tech Transfer, process validation, and CPV documentation and processes. Monitor commercial manufacturing to identify and implement improvement opportunities within approved parameters.
• Collaboration and Expertise: Liaise with development teams, participate in deviations and Change Controls, collaborate with MSAT Lab and Process Leads, and lead improvement projects, providing process expertise where needed.
• Compliance and Training: Work according to cGMP requirements, complete all required trainings within deadlines, and ensure the use of authorized documents for all activities.
• Documentation and Inspections: Keep validation, CPV, and verification documentation up-to-date and inspection-ready, and present these documents during inspections and audits by partners and Health Authorities.

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.
• 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 E-Mail schreiben. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.