Analytical Transfer & QC Readiness Expert
Publication date:
05 February 2025Workload:
100%Contract type:
Unlimited employment- Place of work:Bulle
Make your mark for patients
We are looking for an Analytical Transfer & QC Readiness Expert who is eager to join us in our Patient Supply Quality Control department and be part of our pioneering manufacturing project as an extension of our chemical production, based in our manufacturing site in Bulle, Switzerland.
About the project
As part of our ongoing commitment to innovation and growth in the pharmaceutical industry, we are launching a major project to build and qualify a production unit for a chemical component used in biotech product manufacturing.
This is an exciting opportunity to join our project team in a permanent contract and get involved from the design phase through to the construction, qualification and start-up of the plant.
We are seeking talented professionals to complete our project team and bring this essential facility to life.
About the role
As subject matter expert, you will ensure the transfer, validation, and verification of analytical methods in accordance with procedures, regulatory requirements, and user needs.
You will provide technical expertise in these areas during investigations, Change Controls, and projects, and manage post-transfer activities to ensure the compliance of new analytical methods.
You will be part of the project for 2 to 3 years and after you will join the Patient Supply Quality Control local department.
The role it is based on site at UCB in Bulle, Switzerland.
Periodic travel to Belgium for training purposes will be necessary.
What you’ll do
- Lead/participate in activities linked to analytical AMTE / validation / compendial verification / equivalence in order to support the implementation of new product.
- Participate to the global transfer strategy:
- Write validation/verification/equivalence plans, protocols and reports,
- Review transfer plans, protocols and reports.
- Assess analyses and provide accurate and reliable results for AMTE / validation / Compendial verification / equivalence activities.
- Write analytical procedures, risk analyses and any other quality document.
- Configure instrument/report method in software (Chromatography Data System or standalone)
- Implement methods and analytical knowledge in QC laboratory
- Lead / Participate to deviations / Investigations / CAPA and Change Controls as SME for AMTE / validation / Compendial verification / equivalence activities.
Interested? For this role we’re looking for the following education, experience and skills
- Education: Bachelor and/or master’s degree level in Chemistry/Life/Pharmaceutical Science.
- Experienced in GMP environment
- Practical knowledge of analytical techniques (HPLC/UPLC, GC, KF, RMN a plus).
- Good knowledge of analytical software (Empower) and Lims.
- Basic knowledge of statistics.
- Good level of proficiency with MSOffice tools.
- Excellent communication skills, for communicating with internal and external partners.
- Excellent organization and problem-solving skills.
- 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.
- Good level of spoken and written French and English.
- Team player.
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.