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Bioanalytical Manager in Small Molecule Bioanalytics (m/f/d)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Engineering, Support

Projektbeschreibung

REFERENCE NUMBER:

413765/1

MY DUTIES:

-Ensure the development/transfer and validation of specific and sensitive bioanalytical methods required for the drug candidates and any concomitant/interaction therapies in a given project working closely with the internal labs and external providers (CROs)
-Manage and direct analysis of samples and timelines from non-clinical and clinical studies for the project at CRO labs
-Participate actively in DMPK, clinical and study management sub-teams
-Review protocols and guide project teams in all aspects of bioanalytical work required for the project
-Review data and reports for regulatory submissions
-Support filings and answer any questions coming from the regulatory agencies, as applicable
-Ensure full compliance with the current global and local bioanalytical regulatory guidance
-Remain current and continually develop expertise in bioanalytical sciences of small molecules, including oligonucleotides analysis

MY QUALIFICATIONS:

-PhD degree or equivalent with strong background in analytical chemistry of small molecules
-Profound experience in a bioanalytical or DMPK department (preferably within a pharma company)
-Demonstrated experience in the area of bioanalytics of small molecule drugs including oligonucleotide analysis and CRO monitoring
-Sound knowledge of the GxP, specific to bioanalytical work
-Recent and relevant work experience in a pharma company lab or outsourcing function where regulated bioanalysis is run according to the FDA and EMA guideline
-Excellent communication skills and ability to work in a matrix organization
-Ability to represent function and provide leadership in a multidisciplinary project team
-Excellent knowledge of English (spoken and written)

MY BENEFITS:

-A highly motivated team and an open way of communication

PROJECT INFORMATION:

REMUNERATION DETAILS :

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

Projektdetails

  • Einsatzort:

    Basel Stadt, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    24 MM++

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland