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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)