Senior Associate Scientist

3 weeks ago


Cambridge, Massachusetts, United States Proclinical Staffing Full time

Job Summary:

Proclinical Staffing is seeking a dedicated and detail-oriented Senior Associate Scientist to support stability and specification tasks for siRNA drug substances and drug products in a contract setting.

Key Responsibilities:

  • Manage specification change controls in a GMP setting to ensure compliance and quality.
  • Contribute to general laboratory operations, including data review and authorship/review of technical documentation.
  • Author and review SOPs and protocols in line with company and regulatory guidelines.
  • Contribute data to analytical and stability sections of regulatory submissions and assist with responses to agency requests on these sections.
  • Assess specifications of existing and new products to ensure alignment with company goals.
  • Support in maintaining platform program specification documents to ensure accuracy and completeness.
  • Meet goals supporting studies and defining specifications for new molecules in development to drive business growth.
  • Ensure on-time and compliant completion of stability data to support clinical supply and product registration.

Requirements:

  • Degree in Chemistry, Biochemistry, or related disciplines.
  • Previous experience in a cGMP analytical laboratory environment.
  • Experience with stability studies designed and conducted in accordance with ICH guidelines is preferred.
  • Team player with excellent communication and presentation skills.
  • Experience with HPLC and physico-chemical test methods of oligonucleotides, oligosaccharides, or proteins is preferred.


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