ID EXISTS
POS 5264
Status 10
DJM 1

Specialist Scientist Bioanalytics

Beschreibung: One of our biotech clients in Switzerland is currently seeking freelance support as:Specialist Scientist Bioanalytics (M/F/D) Tasks: Responsible for bioanalytical support of biosimilar development programs, with a particular focus on PK and immunogenicityOversight the compliance and scientific integrity of outsourced bioanalytical work for biosimilar development programsIdentify and oversee bioanalytical laboratories for PK/PD and immunogenicity sample analysisCoordinate CROs or internal bioanalytical resources supporting early Product Development with regards to PK and immunogenicity method development, validation and sample analysisCoordinate and guide the collaboration between bioanalytical laboratories and CROs by performing regular visits and summarize outcome in reportsRequest, review and manage contracts with bioanalytical laboratoriesProvide expertise on data transfer, reconciliation and work with clinical operations and other internal stakeholders during the execution of clinical studiesWork with project management to align timelines and budget with the overall development planMonitor shipments and track stocks of critical reagents at bioanalytical laboratoriesOn bioanalytical and clinical pharmacology and immunology topics, contribute to regulatory submissions and briefing books
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Qualification:
  • Scientific degree (PhD, MD or equivalent) in Biochemistry, Chemistry, Immunology or related fields
  • Both CRO and Pharmaceutical/Biotech industry experience preferred
  • Good knowledge of scientific best practices, GLP and basic knowledge in regulatory guidelines
  • Experience in providing scientific oversight for bioanalytical projects placed at CROs
  • Experience in bioanalytical sciences in e.g. preclinical / clinical studies related to PK, immunogenicity or biomarker assays, diagnostic lab or central lab
  • Must Have: Business fluency in English
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Key data:
  • Start: asap, ideally January 2022
  • Duration: 12 months
  • Workload: minimum 3 days per week, ideally 5 days per week // high flexibility preferred
  • Location: fully remote possible (occasionally on site if required)
Bemerkungen: WANTED: Senior Bioanalytical Scientist (M/W/D). Bitte nehmen Sie Kontakt auf: +49 89 18 90 998 18 oder nadine.muench@k-recruiting.com Skills: Biosimilars, CRO Experience, English
K-RECRUITING Life Sciences Personalberatung - parallax image
Interesse geweckt?
Auf geht's!
Beginn: asap/Januar
Laufzeit: 12 Months
Einsatzort: remote
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