Quality Control Analyst II
Company: Alnylam Pharmaceuticals, Inc.
Posted on: June 7, 2021
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 Quality Control Analyst II will be primarily responsible for
performing routine environmental monitoring (EM) and critical
utility (CU) sampling and testing in support of our new GMP
manufacturing at the Alnylam - Norton facility, 20 Commerce Way,
Norton, MA and supporting the Alewife facility, 665 Concord Avenue,
Cambridge, MA. Secondary responsibility supporting the raw material
program, including analytical testing. The position requires
flexibility with changing priorities.
- Supporting the EM/CU program at the GMP manufacturing site at
the Norton and Alewife facility.
- Perform EM and CU sampling within a new cleanroom
- Perform QC testing (i.e., viable air, total particulate, TOC,
conductivity, bioburden, endotoxin).
- Perform microbial counting and identification using
- Perform trend analysis, troubleshooting, and support
investigations (e.g. excursions and quality events).
- Ensures continuous GMP-compliant state of the laboratory and
- Author and review technical documentation (e.g. SOPs,
- Demonstrated technical ability in interpretation of compendia
(USP, Ph. EUR, JP, etc.).
- Troubleshooting experience are required.
- Secondary support for the Raw Material program including:
- Inspection and sampling of raw materials
- Analytical testing of raw materials (i.e. FTIR, Moisture)
- Minimum education required for this position is a Bachelor of
Science Degree in a scientific discipline (e.g. Microbiology,
- Minimum experience required for this position is 2-3 years of
experience in a GMP laboratory.
- Experience performing EM and CU sampling and testing.
- Familiarity with Compressed Gas and Water for Injection
- Experience with compendia requirements (USP, Ph. EUR, and
- Experience in raw material sampling and analytical testing is
- Ability to travel between domestic sites (Norton, MA;
Alnylam Pharmaceuticals is an EEO employer committed to an
exciting, diverse, and enriching work environment.
Keywords: Alnylam Pharmaceuticals, Inc., Cambridge , Quality Control Analyst II, Other , Cambridge, Massachusetts
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