Analytical Expertise & Validation Specialist

Make your mark for patients

We are looking for anAnalytical Expertise & Validation Specialist who is eager to join us in ourBusiness Acceleration departement, based in Bulle, Switzerland

About the role

• Ensure the transfer/validation/verification of analytical methods in line with the procedures, the regulatory requirements and user needs.
• Provide expertise in the transfer/validation/verification of analytical methods during investigations, Change Controls and projects.
• Present the transfer/validation/verification documentation during inspections and audits by health authorities and partners.

Who you’ll work with

You will work in a team of 5 people. 3 Specialists, 1 Lead, 1 Manager.

Team spirit and autonomy are the watchwords of the team.

What you’ll do

Analytical :

• Lead/participate in activities linked to analytical AMTE / validation / equivalence,
• Participate to the global transfer strategy:
• Write analytical procedures, risk analyses and any other quality document,
• Take part in the QC laboratory software administration for new methods,
• Transfer analytical knowledge to the QC laboratory (coaching),
• Be involved in the good running of the laboratory in general.

Equipment :

• Take part in laboratory equipment acquisition as SME,
• Write procedures for new equipment,

Projects & Continuous Improvement :

• Participate to the continuous improvement of analytical documentation and AMTE / validation / equivalence processes,
• Ensure adherence to project planning,
• Lead analytical AMTE / validation / equivalence-related projects within the group,
• Participate in technical or organizational cross-functional projects as well as in specific manufacturing projects for activities related to AMTE / validation / equivalence,
• Act as SME during projects involving AMTE / validation / equivalence activities.

Quality :

• Work according to GMP requirements,
• Assess analyses and provide accurate and reliable results for AMTE / validation / equivalence activities,
• Lead / Participate to deviations / Investigations / CAPA and Change Controls as SME for AMTE / validation / equivalence activities,
• Present the AMTE / validation / equivalence documentation during inspections and audits by health authorities and partners.

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

• In-depth knowledge of cGMPs,
• Experience in analytical and instrumental chemistry and / or biochemistry (LC, GC, KF, UV, IR, etc.),
• Analytical knowledge & experience,
• Knowledge in microbiology and cell base assay could be a plus
• Experience in a QC department of a pharmaceutical or biological firm,
• Good level of spoken and written French and English,
• Excellent communication skills, for communicating with internal and external partners,
• 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,
• Sense of responsibility and ownership,
• Sense of initiative

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 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.