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Proclinical Logo Proclinical · Research and Development

Senior Associate Scientist

United States, Cambridge 45.00 - 50.00 USD / Hour · Job Posted January 18, 2026
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Job Description

Proclinical is seeking a Senior Associate Scientist to support the development and management of specifications for siRNA drug substances and drug products. This role involves working in a GMP environment and contributing to various technical and operational aspects, including data review, documentation, and regulatory submissions.

Job Responsibility

  • Initiate and manage specification change controls in a GMP setting
  • Review data and author/review technical documentation
  • Provide technical support as needed
  • Author and review SOPs and protocols in compliance with company and regulatory guidelines
  • Contribute to data review and analytical/stability sections of regulatory submissions
  • Assist with responses to agency requests related to these sections
  • Assess specifications for existing and new products
  • Support the maintenance of platform program specification documents
  • Ensure timely and compliant review and verification of stability data to support clinical supply
  • Implement stability and release specifications for product registration

Requirements

  • Degree in Chemistry, Biochemistry, or a related field
  • Experience in a cGMP analytical laboratory environment
  • Familiarity with stability studies designed per ICH guidelines (preferred)
  • Strong teamwork and adaptability skills
  • Excellent communication and presentation abilities
  • Experience with HPLC and physico-chemical test methods for oligonucleotides, or alternatively, for oligosaccharides or proteins (preferred)
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