Analytical Expertise & Valid. Specialist

UCB S.A.

Ver: 139

Día de actualización: 20-03-2024

Ubicación: Bulle Fribourg FR

Categoría: Farmacéutica / Química / Biotecnología

Industria:

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Contenido de trabajo

Make your mark for patients.

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?


To strengthen our Analytical Expertise & Validation team, as part of the Analytical & Process Validation group, based in our manufacturing site in Bulle, Switzerland, we are looking for a talented individual to fill the position of: Analytical Expertise & Validation Specialist.


As an Analytical Expertise & Validation Specialist, you will coordinate activities related to the lifecycle of analytical methods with our corporate and internal stakeholders, and bring analytical procedures into conformity following regulatory changes, and the establishment of new monographs.


You like to work in an
environmentwhere you can:

  • Be part of an engaged and professional team.
  • Connect with internal partners in Switzerland and Belgium.
  • Anticipate, plan and coordinate the implementation of changes in Bulle.
  • Lead & execute activities related to the Lifecycle of analytical methods.
  • Lead & execute co-validations, transfers and verification protocols for all lifecycle-related activities.
  • Show a pro-active, customer-oriented, results-driven, positive, can-do attitude.
  • Be engaged to impact patients’ lives.


You will
contributeby:

  • Leading activities related to the Lifecycle of analytical methods for mainly non-biological methods related to our Neuro and Allergy products (and, if needed, for biological methods) for Bulle site, including:
    • The short, mid- and long-term identification of changes to come in collaboration of our global partners.
    • The definition of the change strategy for Bulle site.
    • The planning and coordination of the changes together with our stakeholders in Belgium and Bulle up until implementation.
    • The preparation/execution of the AMTE activities.
    • The implementation of the changes in the laboratory.
  • Managing mainly non-biological analytical transfers between the different UCB laboratories or with CMOs, CLOs and partners, as recipient or sender laboratory:
    • Write, review and approve transfer or validation documents (protocols and reports),
    • Create analytical verification documents (protocols and reports),
    • Plan and organize testing for AMTE/verification activities,
    • Provide support to analyse test results,
    • Lead investigations in the event of non-compliant results,
    • Ensure the transfer of knowledge of methods to the laboratory as well as the necessary training,
    • Ensure adherence to the schedule in terms of activities and resources,
    • Configure methods in Empower as well as custom fields.
  • Acting as SME for the acquisition of new laboratory equipment.
  • Providing expertise in analytical methods validation / AMTE / verification during investigations, Change Controls and projects.


I
nterested? For this position you’ll need the followingeducation, experience and skills:

  • Bachelor / master’s degree in Life Sciences / Biology / Chemistry or equivalent.
  • Broad knowledge of cGMP governmental regulations and guidelines, and the ability to interpret and apply. Knowledge of ICH and regulatory guidelines.
  • Experience of at least 5 years in an analytical laboratory (pharma and/or biotech), including a significant experience in physico-chemical analytical methods execution and AMTE/validation.
  • Ability to connect and communicate with partners and stakeholders across the UCB organization, and establish durable and profitable work relations so as to anticipate changes to come.
  • Good knowledge of chemical/biological analytical techniques (HPLC, UPLC, GC, dissolution, UV, KF…) and compendial methods (Ph. Eur, USP).
  • Good knowledge of SDMS (Empower-Waters) and LIMS (Labware) systems.
  • Team player with the ability to connect and communicate with partners and stakeholders across the UCB organization.
  • In-depth analytical thinking, statistical analysis, problem solving and technical investigation skills, with proven experience in change management.
  • Languages: fluent in French, technical English.


Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.


About us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.


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.

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Plazo: 04-05-2024

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