Scientist II, Analytical Development Specialist

2 weeks ago


Waltham Massachusetts, United States AbbVie Full time
Job Summary

AbbVie is seeking a highly skilled Scientist II, Analytical Development to support the development and implementation of analytical methods for late-phase antibody-drug conjugate (ADC) development.

Key Responsibilities
  • Support Analytical Method Lifecycle Activities: Collaborate with external AD/QC laboratories to ensure the development and validation of analytical methods for IPC, release, and stability testing.
  • Manage Reference Standard Programs: Oversee the development, qualification, and management of antibody and ADC reference standards for all development phases.
  • Author and Review Documentation: Develop and review protocols, reports, and test methods related to analytical method development and validation.
  • Collaborate with Cross-Functional Teams: Work closely with QA, manufacturing sciences, regulatory CMC, and supply chain to support program objectives.
  • Perform Statistical Analysis: Conduct statistical analysis of batch data to support specification setting and product comparability studies.
  • Support Regulatory CMC Activities: Assist with regulatory filings, information requests, and in-country registration testing.
Requirements
  • Ph.D. in Analytical Chemistry or related field.
  • Minimum 5 years of experience in analytical method development and validation.
  • Strong understanding of GMP regulations and industry standards.
  • Excellent communication and collaboration skills.


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