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Scientist, Method Transfer Specialist

2 months ago

Bothell, Washington, United States Synectics Inc Full time
Job Summary

We are seeking a highly skilled Method Transfer and Validation Scientist to join our Development QC team at Synectics Inc.

Key Responsibilities
  • Lead method transfer and validation efforts to ensure compliance with cGMP and regulatory expectations.
  • Support project leads for method transfer and validation internally and externally for assigned programs.
  • Author or review protocols and reports for method transfer and/or method validation or method bridging.
  • Plan and track method transfer and/or method validation deliverables.
  • Collaborate with internal and external stakeholders to ensure seamless method transfer and validation processes.
  • Review and verify method transfer and/or method validation data, perform data analysis, and provide recommendations for improvement.
Requirements
  • Bachelor's degree in life science or related field (post-graduate degree preferred).
  • 8+ years of experience in pharmaceutical/biological drug product development, analytical chemistry, and/or QC in a regulated biotechnology or pharmaceutical company.
  • Expertise in designing and evaluating method validation and transfer studies, including partial re-validation, co-validation, and cross-validation.
  • Strong technical writing skills for authoring methods, validation, and transfer studies/protocols/reports.
  • Excellent project management skills, with experience managing multiple projects simultaneously.
  • Strong data interpretation and method troubleshooting skills, with a sound scientific judgment.
  • Good time management skills, with attention to detail and a desire to achieve team and individual goals.
  • Excellent communication skills, with the ability to lead a team and influence other leaders or cross-functional team members.
  • Understanding of regulatory guidance and requirements (ICH, CFR, general guidance) pertaining to method transfer and method validation, regulatory submission, and method transfer validation in QC.