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Bioanalytical Scientific Manager

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Research & Early Development
Job ID:  65756

Bioanalytical Scientific Manager

 

Location: Braine l’Alleud, Belgium

 

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 specializing in Cell and Gene Therapy.

 

Role and Responsibilities:

  • Accountable for the design and execution  of the bioanalytical strategy focusing on programs from pre-clinical development to late stage clinical development and post marketing activities
  • Help drive overall department strategy for the emerging cell and gene therapy programs, with a particular focus on bioanalytical needs to support tissue distributions studies, immunogenicity assessment and biomarker evaluations.
  • Provide insights to develop internal  technical capabilities as well as  outsourcing strategies for cell and gene therapy programs
  •  Assures bioanalytical tasks are executed with good scientific quality, within the appropriate quality systems, and within the agreed upon timelines.
  • Accountable for oversight of  all project bioanalytical needs executed internally or through  external vendors.
  • Act as sole representative within project teams interfacing with discovery colleagues, pre-clinical and clinical development colleagues
  • Play a key role is defining and executing biomarker strategy for programs under direct control as well as offering insight to other colleagues within the team
  • Collaborate with multiple internal and external stakeholders including Therapeutic Area experts , Non-Clinical safety, Quantitative Clinical Pharmacology, Translational Medicine, Clinical Development  and external partners.
  • Active contributor to  preclinical and clinical study design and  ensuring effective execution of studies  ( e.g.  study concept, protocol development ,  statistical analysis plans and study reporting)
  • Support submissions to regulatory agencies including but not limited to preparation of INDs, BLAs, and when required direct interactions with regulatory agencies such as FDA, EMA, PMDA, NVISA and SFDA.,
  • Drive effective collaboration with CRO partners thought direct oversight, vendor audits and vendor governance interaction.
  • Ensure appropriate  quality systems are adhered to (GLP, GcLP, Good Clinical Practice)

 

Skills and experience: 

 

  • Experience in the pharma or CRO industry supporting regulatory bioanalysis ideally with experience in cell and gene therapy programs
  • Knowledge of multiple bioanalytical techniques such as LC-MS/MS, Immunoassay, flow cytometry, quantitative PCR or immunohistochemistry
  • Experience in Neuroscience, Immunology or  Oncology programs would be advantageous
  • Expertise in a broad range of bioanalytical techniques including but not limited to immunohistochemistry, genomic, transcriptomic or proteomic for biomarkers determination within a clinical setting would be ideal
  • Demonstrated ability to evaluate project needs, collaborated with a broad cross sections of scientific and operational colleagues as well as a proven track record influencing strategic projects decisions .
  • 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  emerging industry lead technical publications ,   published international guidance issued  by regulatory agencies such as FDA, EMA
  • Previous experience managing contract research organizations

 

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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