Scientist, Analytical Development

Company: Alnylam Pharmaceuticals, Inc.
Location: Cambridge
Posted on: June 8, 2021

Job Description:

Scientist, Analytical Development

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 scientist will contribute to development and implementation of new analytical technologies in Analytical Science group. The scientist will be responsible for development, qualification, scale up and transfer of HPLC based assays for identification, characterization, and impurity determination of siRNA's and their formulations. Develop strategies for impurity profiling of new development candidates and raw materials. Drive innovative platform improvements by deployment of novel workflows to increase operational efficiency and high throughput automation, and support the expansion of the state of the art impurity characterization toolbox by bringing novel ideas to the team Author development reports and regulatory filing documents, and manage analytical activities internally and externally.

Summary of Key Responsibilities

For the portfolio of pre-clinical and clinical programs at Alnylam -

• Develops, qualifies and transfers HPLC and mass spectrometric based CMC assays (sequence verification, impurity characterization, structure confirmation) for new molecules entering development.
• Supports development and implementation of Multi-D siRNA impurity characterization workflows at multiple purification scales.
• Maintains a thorough hands on understanding of HPLC and MS fundamentals and supports troubleshooting of hardware and software in an efficient manner.
• Contributes to technical discussion on LC method enhancement and supports method-transfer troubleshooting to internal/external collaborators.
• Identifies impurity profiles and provides data to set impurity limits for molecules in development.
• Performs testing of late development siRNA's candidates and their formulations for their characterization.
• Authors and reviews method development reports and authors SOP's for test methods.
• Authors characterization sections of regulatory submissions and respond to agency questions.
• Supervises technical maintenance of mass spectrometers and HPLC instruments by contractors for Analytical CMC. Trains new laboratory employees in assay techniques.
• Contributes to characterization, analytical and stability sections of regulatory submissions and responds to agency requests on these sections.
• Being a self-motivated independent contributor that works well in a matrix team for ensuring deliverables are met

Qualifications

• M.S or Ph.D. in Analytical Chemistry, Biochemistry or related disciplines.
• M.S. with Six plus years industrial experience.
• Ph.D. with two plus years industry or post graduate experience
• Hands on experienced with HPLC and Mass Spectrometric methods. Familiarity with analytical and preparative LC hardware and CDS software from Waters (Empower and Masslynx). Experience with oligonucleotide based assay strongly preferred.
• Good communication skills within organization.
• Good knowledge of statistical methods and computer skills.

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

Keywords: Alnylam Pharmaceuticals, Inc., Cambridge , Scientist, Analytical Development, Other , Cambridge, Massachusetts