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Bioanalytical Scientific Manager

Via Pauwels Consulting

Published on Jobat.be 13 days ago

Pauwels Consulting is a Belgian consulting firm with more than 520 experts in engineering, life sciences and IT. We offer consulting, project management and recruitment services to leading companies in Belgium and beyond. We have offices in Belgium, France, Germany and Switzerland (https://www.pauwelsconsulting.com/about/contact/) .

Bioanalytical Scientific Manager

Job description

  • Accountable for the design of the bioanalytical strategy and the execution thereof (Pharmacokinetic, Immunogenicity and Biomarker) 
  • Ensuring that bioanalytical tasks are executed with good scientific quality, within the adequate quality system, and within the agreed timelines
  • Departmental representative in multidisciplinary project teams 
  • Collaborating with multiple internal and external stakeholders (therapeutic area, quantitative clinical pharmacology, clinical operations, non-clinical safety, contract research organisations, …) to build and execute the bioanalytical strategy 
  • Participating in preclinical study design and documentation, and in clinical study design and documentation (lab manual, protocol, SAP,…) 
  • Supporting of regulatory document writing (IB, IND, scientific advice)
  • Supporting scientific advice meetings with regulatory authorities (EMA, PMDA, FDA) 
  • Overseeing the writing of the Immunogenicity Risk Assesment 
  • Participating in vendor governance through technical and study audits. 
  • Ensuring compliance towards the adequate quality systems (GLP, GcLP, GCP) 

Profile

  • Experience in the pharma or CRO industry supporting regulatory bioanalysis of large molecules 
  • Extensive knowledge of a range of bioanalytical techniques including LC-MS/MS, Immunoassay, flow cytomety and quantitative PCR to support the analysis of Pharmacokinetic (NBE), Immunogenicity and Biomarker endpoints 
  • Extensive knowledge of the latest regulatory standards required for GXP studies including international guidance’s published by regulatory agencies such as FDA, EMA 
  • Experience with multispecific NBEs is a plus
  • Demonstrated ability to collaborate in and influence multidisciplinary teams 
  • Previous experience managing contract research organisations 

Offer

  • Challenging projects based on your interests and skills
  • Personal follow-up and clear, transparent communication both before and after commencement of employment
  • Possibility to follow extra training
  • Inspiring network events and legendary after work drinks
  • Strong network of industry leading clients
  • Expertise within IT, Engineering and Life Sciences
  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
Nivelles

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Characteristics

Requirements

  • Master (University or Higher Education Long Type)

Offer

  • Permanent
  • Independent
  • Full-time

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