Associate Scientist II, Stability

Overview

Alnylam is the world's leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine's Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.

The Associate Scientist, Stability will be responsible for stability support of siRNA isolated intermediates, drug substances, drug products, and critical raw materials.

Summary of Key Responsibilities

• Perform analytical testing of siRNA drug substances, drug products and critical raw materials.
• Analyze and trend data within the context of stability expectations and specifications.
• Author and review stability reports.
• Provide sound statistical interpretation of stability data, and their relation to lifetime specifications.
• Support outsourced GMP/GxP stability programs
• Contribute data to characterization, analytical, and stability sections of regulatory submissions. Assist with responses to agency requests on these sections.
• Contribute to investigations of stability Out of Trend (OOT) results.
• Provide stability expertise to the assessment of temperature excursions.

• BS or MS in Chemistry, Biochemistry or related disciplines.
• Minimum of three years of previous experience in a cGMP analytical laboratory environment.
• Must be a team player and open to change.
• Must have excellent communication and speaking skills. Can make presentations on stability findings outside department.
• Preferred - previous experience with stability studies designed and conducted in accordance with ICH Guidelines.
• Preferred - experience with HPLC and physico-chemical test methods of oligonucleotides. Alternatively - experience with HPLC and physico-chemical test methods of oligosaccharides or proteins.