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Bioanalytical Scientific Manager

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Research & Early Development
Job ID:  64807

Bioanalytical Scientific Manager

 

Location: Slough, GB or Braine-L’Alleud, BE

 

 

UCB is a leading global biopharmaceutical company which is dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products across the fields of Central Nervous Systems (CNS) and Immunology. The organization employs some 9,000 individuals across approximately 40 countries.

 

Within the UCB Development Sciences team, the Translational Biomarker and Bioanalysis department is currently looking for enthusiastic scientists capable of working globally with a diverse group of partners inside and outside UCB to contribute to bringing solutions to patients.

 

For this department we are currently looking for a Bioanalytical Scientific Manager.

 

Role and Responsibilities:

  • Accountable for the design of the bioanalytical strategy and the execution thereof (Pharmacokinetic, Immunogenicity and Biomarker)
  • Assures bioanalytical tasks are executed with good scientific quality, within the appropriate quality systems, and within the agreed upon timelines. This entails overseeing the execution by internal facilities or external vendors.
  • Departmental representative in multidisciplinary project teams
  • Collaborate with multiple internal and external stakeholders (therapeutic area, quantitative clinical pharmacology, clinical operations, non-clinical safety, contract research organizations, …) to build and execute the bioanalytical strategy
  • Participate in preclinical study design and documentation, and in clinical study design and documentation (lab manual, protocol, SAP,…)
  • Support regulatory document writing (IB, IND, scientific advice). Provide input to and occasionally attend scientific advisory meetings with regulatory authorities (EMA, PMDA, FDA)
  • Oversee the writing of the Immunogenicity Risk Assessment
  • Participate in vendor governance through technical and study audits.
  • Compliant towards the adequate quality systems (GLP, GcLP, Good Clinical Practice)

 

Skills and experience: 

 

  • Experience in the pharma or CRO industry supporting regulatory bioanalysis of large molecules
  • Knowledge of a range of bioanalytical techniques such as LC-MS/MS, Immunoassay, flow cytomety and quantitative PCR
  • The ideal candidate will have experience in gene therapy or oncology programs
  • Expertise in a broad range of bioanalytical techniques including but not limited to immunohistochemical, genomic, transcriptomic or proteomic for biomarkers determination within a clinical setting would be ideal
  • Extensive experience in technical and scientific aspects of translational biomarker assessment in drug development
  • Knowledgeable in translating context of use of biomarkers in expected assay specifications
  • Knowledge of the latest regulatory standards required for GXP studies including international guidance’s published by regulatory agencies such as FDA, EMA
  • Previous experience managing contract research organisations
  • Demonstrated ability to collaborate in and influence multidisciplinary teams

 

To apply please go to www.ucb.com/careers.

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers.

 


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