Scientist, Analytical Development
Company: Alnylam Pharmaceuticals, Inc.
Posted on: June 8, 2021
Scientist, Analytical Development
Alnylam is the world's leading RNA interference (RNAi)
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
- Develops, qualifies and transfers HPLC and mass spectrometric
based CMC assays (sequence verification, impurity characterization,
structure confirmation) for new molecules entering
- Supports development and implementation of Multi-D siRNA
impurity characterization workflows at multiple purification
- 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
- 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
- M.S or Ph.D. in Analytical Chemistry, Biochemistry or related
- M.S. with Six plus years industrial experience.
- Ph.D. with two plus years industry or post graduate
- 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
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