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SASanofi-Aventis Deutschland GmbH

Analytical Lead and Expert Preclincal Bioassays(m/w/x)

Frankfurt am Main
from 79,104 - 118,656 / year
Full-timeOn-siteSenior
AI/ML

Leading analytical activities for biologics, coordinating insulin-bioassays at external suppliers. 5+ years biopharmaceutical development and manufacturing experience required. 14-week paid family leave, childcare benefits.

Requirements

  • 5+ years development and manufacturing biopharmaceutical products
  • Experience in analytical sciences
  • Experience with analytical transfers
  • Experience with bioassays
  • Experience with automation
  • Experience with development
  • Experience with regulatory requirements
  • Experience with dossier writing
  • cGMP knowledge
  • HA regulations knowledge
  • Interactions with HA
  • Active decision-making
  • Enjoyment of interdisciplinary collaboration
  • Openness and winning with people
  • Self-employment
  • Organizational skills
  • Purposefulness
  • Ability to present complex contexts accurately
  • Ability to present complex contexts comprehensibly
  • Risk anticipation
  • Proactive solutions
  • Effective solutions
  • Innovative solutions
  • PhD or Master in Science
  • Chemistry degree
  • Biochemistry degree
  • Biotechnology degree
  • Chemical engineering degree
  • Pharmacist degree
  • Fluency in English writing
  • Fluency in English verbally
  • Fluency in German writing
  • Fluency in German verbally

Tasks

  • Serve as Analytical Lead for product teams
  • Oversee analytical activities for biologics
  • Coordinate insulin-bioassays at external suppliers
  • Support new product launches
  • Represent Global MSAT Analytical in CMC teams
  • Maintain knowledge of assigned products
  • Ensure analytical work execution internally and externally
  • Support characterization, comparability, and process development
  • Coordinate bioassay experiments at external suppliers
  • Develop analytical control strategy
  • Conduct risk assessments for new products
  • Manage comparability activities for process changes
  • Lead ALCM activities including automation
  • Oversee assay development and transfer
  • Provide SME support for assigned products
  • Contribute to regulatory dossiers
  • Respond to authority questions

Work Experience

  • 5 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent
  • GermanBusiness Fluent

Benefits

Healthcare & Fitness

  • High-quality healthcare

Mental Health Support

  • Prevention programs

Job Security

  • Long-term illness coverage

Generous Parental Leave

  • 14-week paid family leave

Childcare

  • Childcare benefits

Corporate Discounts

  • Company employee benefit programs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sanofi-Aventis Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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