Lead Analytical Scientist - Stability & Regulatory Submissions
Alnylam Pharmaceuticals
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Résumé du poste
Alnylam Pharmaceuticals in Cambridge, MA seeks a Principal Associate Scientist (Multiple Positions) to perform analytical testing of siRNA drug substances, drug products, and critical raw materials. You will author stability protocols, reports, and SOPs, and contribute to design and execution of stability studies using DoE principles.
The role requires a Master’s or Bachelor’s with extensive experience in analytical chemistry, cGMP, and regulatory documentation.
Qualifications
- Experience with analytical instruments and techniques (HPLC, UPLC, UV/Vis) and pH
- Experience in analytical data review, interpretation and trending
- Experience with statistical analysis of data
- Experience in investigations, deviations and change controls
- Experience with stability studies under ICH guidelines
- Strong technical writing abilities
- Experience in analytical laboratory CGMP environment
Responsabilités
- Perform analytical testing of drug substances and products
- Author and review stability protocols, reports and SOPs
- Contribute to DoE-based stability studies (freeze-thaw, thermal cycling, device compatibility)
- Support GMP/GxP stability programs and data interpretation
- Assist with regulatory submissions sections and agency responses
Connaissances
Formation
Outils
Description du poste
Alnylam Pharmaceuticals in Cambridge, MA seeks a Principal Associate Scientist (Multiple Positions) to perform analytical testing of siRNA drug substances, drug products, and critical raw materials. You will author stability protocols, reports, and SOPs, and contribute to design and execution of stability studies using DoE principles.
The role requires a Master’s or Bachelor’s with extensive experience in analytical chemistry, cGMP, and regulatory documentation.
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