Scientist - Drug Product Development (e&l)

alvotech.is

Design e&l studies
Evaluate material compatibility
Ich and usp guidelines
Design, plan, and oversee extractables and leachables studies for primary packaging systems, process contact materials, and delivery devices used in liquid and lyophilized drug products

Job Summary

  • Design, plan, and oversee extractables and leachables studies for primary packaging systems, process contact materials, and delivery devices used in liquid and lyophilized drug products.
  • Collaborate cross-functionally with formulation, analytical development, quality, regulatory, and external testing partners to ensure drug products meet the highest safety and compliance standards.
  • Join a collaborative, science-driven environment where you'll have the opportunity to make a direct impact on the development of biosimilars.

Matching Summary

Design, plan, and oversee extractables and leachables studies for primary packaging systems, process contact materials, and delivery devices used in liquid and lyophilized drug products.

Skills & Requirements

Must-have

  • design E&L studies
  • evaluate material compatibility
  • ICH and USP guidelines
  • drug product development
  • analytical development

Nice-to-have

  • science-driven environment
  • collaborative team
  • professional growth opportunities
  • international work culture
  • diversity and inclusion

Key Requirements

  • MSc or PhD degree
  • 2-5+ years industry experience
  • E&L study design experience
  • Regulatory guidance understanding
  • Excellent communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter