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Quality Control Analyst II

Company: Alnylam Pharmaceuticals, Inc.
Location: Cambridge
Posted on: June 7, 2021

Job Description:

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 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.

Key Responsibilities

  • 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 facility.
  • Perform QC testing (i.e., viable air, total particulate, TOC, conductivity, bioburden, endotoxin).
  • Perform microbial counting and identification using MALDI-TOF.
  • Perform trend analysis, troubleshooting, and support investigations (e.g. excursions and quality events).
  • Ensures continuous GMP-compliant state of the laboratory and inspection readiness.
  • Author and review technical documentation (e.g. SOPs, protocols, reports).
  • 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)

Qualifications

  • Minimum education required for this position is a Bachelor of Science Degree in a scientific discipline (e.g. Microbiology, Biology, Biochemistry).
  • 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 Systems.
  • Experience with compendia requirements (USP, Ph. EUR, and JP).
  • Experience in raw material sampling and analytical testing is desirable.
  • Ability to travel between domestic sites (Norton, MA; Cambridge, 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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