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Senior Associate Scientist
2 months ago
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 they meet quality and regulatory standards.
- 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 ensure timely and compliant completion.
- Implement stability and specifications for product registration to ensure regulatory compliance.
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.
