Principal Associate Scientist, Stability
Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need. Our first medicine, the first-ever RNAi therapeutic, has recently been approved by the FDA in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition, Alnylam has four investigational medicines in late-stage development. www.alnylam.com. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work in 2015, 2016, and 2017.
The Principal 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.
Author and review stability protocols, reports and SOPs.
Design and execute special use stability using sound DoE principles. Studies include freeze-thaw, thermal cycling, compatibility with intended injection device, and in-use studies.
- Support outsourced GMP/GxP stability programs for drug substance and drug product.
Provide sound statistical interpretation of stability data, and their relation to release and lifetime specifications.
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.
Must be a team player and open to change.
Must have excellent communication and speaking skills. Can make presentations on stability findings outside department.
BS or MS in Chemistry, Biochemistry or related disciplines.
Minimum of three years of previous experience in an analytical laboratory environment, cGMP preferred.
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.
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.