MSAT Upstream Process Transfer Lead

Job content

Make your mark for patients

We are looking for a MSAT Upstream Process Transfer Lead who is aleader driven by initiatives and solutions to join us in our Global Biologics Manufacturing Sciences & Technology (MSAT) Tech Transfer team, based in Braine-l’Alleud, Belgium.

About The Role

The Upstream (USP) Process Transfer Lead is responsible for delivering on all USP Process Transfer responsibilities by managing and leading a cross-functional matrix team of Subject Matter Experts.

Responsibilities

The USP Process Transfer Lead is responsible for transfer of late-stage and commercial biologics Upstream processes into both internal and external commercial scale facilities by

• Taking ownership of late-stage and commercial biologics upstream manufacturing processes.
• Acquiring and maintaining process expertise for late-stage and commercial products.
• Leading cross-functional USP Process Transfer/Process Validation teams.
• Driving USP Process Transfers from Development to Internal Manufacturing and CMO’s.
• Leading the Upstream part of commercial-scale Process Validations.
• Providing routine (on-the-floor) support during manufacturing campaigns.
• Providing deviation and investigation support.
• Leading Continuous Process Verification (CPV) activities.
• Leading/Supporting Lifecycle Management (LCM) activities.
• Improving the understanding, robustness and economics of commercial manufacturing processes.
• Supporting Regulatory inspections and filings.

Who You Will Work With

• Pieter Jacobs as your Manager.
• Your 2 team members as well as many other peers and partners at transversal level.

What You’ll Do

• Support the setup of the MSAT Tech Transfer team.
• Manage the MSAT USP Process Transfer and Validation activities.
• Provide Process Transfer leadership.
• Ensure that appropriate MSAT procedures are developed and continuously improved upon to ensure rapid, efficient and accurate Process Transfers, LCM, CPV, …
• Author and review technical protocols/reports and ensure a high scientific and quality standard.
• Organize routine (on-the-floor) support during manufacturing campaigns.
• Provide deviation and investigation support to Manufacturing.
• Lead/drive/support CPV and LCM activities, as required.
• Ensure support for Regulatory inspections and submissions.
• Build and maintain good working relationships with stakeholders (e.g., Manufacturing, Engineering, QA, Process Development, …), both internal and external.
• Establish and maintain familiarity with contemporary industrial standards, policies, best practices and technologies.

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

• PhD or master’s degree or equivalent experience in a relevant scientific discipline.
• At least 8 years of experience in the biopharmaceutical industry in upstream bioprocessing as USP SME.
• Experience in leading Technology/Process Transfer projects and scale-up of biologics drug substance processes.
• Good understanding of biopharma operations and cGMP.
• Proven Project Management skills.
• Very good knowledge of English (both oral and written); knowledge of French is a plus.

Soft Skills

• Strong communication skills: ability to communicate effectively and connect with peers from different functions (matrix organization) to ensure projects are delivered.
• Very good technical writing skills.
• Excellent analytical thinking and problem-solving skills.
• Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity.
• Ability to both see the bigger picture and understand operational details.

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 for 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.

Learn moreabout sustainability at UCB and how it is integrated into our business approach.

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/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.