Description
We are looking for a
Clinical Bio Analytical Monitor NOVJP (m/f)
Reference: -en
Start: 03/18
Duration: 8 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Take the full responsibility for outsourced activities for bio analytical support of small molecule, LMW compound from FiH till post marketing
- In charge of numerous projects
- Manage the complete bio analytical strategy for various external vendors (independently analyse and interpret data from different experiments performed by external vendors, draw relevant conclusions and design next experiments/validations)
- Independently supervise the outsourcing process for clinical studies sample analysis (provide input to clinical documents, coordinate internal and external timelines and monitor quality of data generated by external vendors)
- Interact with PK expert, project teams and ensure proper priorities of activities at CROs
- Participate in meetings for bio analytical outsourcing strategy, select external vendors and review CRO performances
- Act as BA sub-team member in PKS PTM team from FiH onwards
- Provide regulatory document (e.g. CTD2.7.1) for submission
Your qualifications
- Profound experience in this role or equivalent training
- PhD or MSc in the domain of chemistry, biology and/or analytical chemistry
- Experience and knowledge of LC-MS, pharmacokinetics and GLP
- Knowledge in cutting edge technologies
- Totally independent in developing and validating new analytical methods
- Total independence in software usage (e.g. LIMS, mass spectrometric software and MS Office)
- Interpretation of data produced with critical view
- Ability to perform all lab jobs independently
- Excellent knowledge and application of internal procedures and international guidelines
- High flexibility in daily work within BA
- German and English spoken and written
Skills:
- CRA