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BOBoehringer Ingelheim

Senior / Principal Scientist Peptides Analytics(m/w/x)

Biberach
Part-timeWith Home OfficeManagement

You will drive the development of life-changing therapeutic peptides by leading analytical teams and managing quality control strategies from initial testing through to regulatory approval.

Requirements

  • Master's degree in chemistry, biochemistry, pharmacy, or doctorate
  • Several years of relevant professional experience
  • Expertise in manufacturing, control, or regulatory requirements
  • Knowledge of drug product development
  • Leadership skills and resilience
  • Confident manner and team-oriented working
  • Fluency in German and English
  • Years of experience in international context
  • Strong expertise in therapeutic peptides requirements
  • Good knowledge of pharmaceutical product development
  • Management experience in line or matrix

Tasks

  • Develop specifications and quality control methods
  • Validate methods for synthetic peptide parenteral products
  • Lead and support a team of analytical technicians
  • Plan and monitor GMP stability tests
  • Determine shelf-life for clinical and commercial supplies
  • Supervise GMP release testing for investigational products
  • Support the Head of Quality Control
  • Coordinate analytical method transfers to QC units
  • Collaborate with international process and production teams
  • Plan CMC work packages for product development
  • Draft analytical documentation for regulatory approvals
  • Respond to inquiries from regulatory authorities
  • Develop holistic control strategies for combination products
  • Represent product analytics in interdisciplinary teams
  • Prepare internal guidance for peptide development

Work Experience

approx. 4 - 6 years

Education

Master's degree

Languages

GermanBusiness FluentEnglishBusiness Fluent

Tools & Technologies

therapeutic peptides

Benefits

Flexible Working

  • Occasionally remote working options
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