Bioanalytical Scientific Manager (m/f)
That's XPE. For one of our clients we are looking for: Bioanalytical Scientific Manager (m/f) Organisation description:
The Translational Biomarker and Bioanalysis department is responsible for the design and execution of bioanalytical strategies (PK, Biomarkers and Immunogenicity) throughout the whole portfolio and from the drug discovery to the drug development and post-marketing stage.rug discovery to the drug development and post-marketing stage.Job description:
• 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 adequate quality system, 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 organisations, …) 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). Supports scientific advice meetings with regulatory authorities (EMA, PMDA, FDA)
• Oversee the writing of the Immunogenicity Risk Assesment
• Participate in vendor governance through technical and study audits.
• Compliant 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
• Previous experience managing contract research organisations
• Demonstrated ability to collaborate in and influence multidisciplinary teams
• Experience with multispecific NBEs is a plus
You will be hired as a contractor for XPE Pharma & Science.
The project is temporary for a year, but could be extended.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713