Bioanalytical Monitor

Job description

Job Description

As a member of the Biologics bioanalytical outsourcing group within Pharmacokinetics Sciences (PKS), the successful candidate will coordinate and monitor bioanalytical activities outsourced to external partners.
He/she will act as the interface with the clinical teams:
• to manage transfer and validation of bioanalytical assays for PK, PD and Immunogenicity assessments for Large Molecules
• to coordinate clinical sample analysis according to the study needs and timelines • to perform quality check of the bioanalytical data and reports before their release

Major Accountabilities:
• Monitor transfer and validation of bioanalytical assays for assigned projects.
• Support clinical teams to set up the clinical trials by providing bioanalytical inputs on sample collection; bioanalytical method, bioanalytical data release
• Provide CROs with the required information to start their activities (Study protocol, method description, timelines ...)
• Monitor outsourced activities at CRO during the course of the studies
• Help CROs for trouble-shooting when required
• Review and release CRO data and reports
• Mediate and manage contact and communication with internal customers and external partners

Desired profile

Minimum requirements

• MSc, preferably PhD
• Several years of experience in the pharmaceutical industry or CRO in comparable positions
• Strong background in ligand binding assays (different plate-based methods, label-free methods like Biacore or other, RIA, cell based assays, etc...) and immunological tools
• Experience in bioanalytics and PK-PD interpretation, including high throughput analysis for clinical samples.
• Good understanding of bioanalytics for large molecules
• Familiarity with regulatory guidelines for bioanalytics (GLP / GCLP) would be an advantage