Quality Control Analyst II at Alnylam Pharmaceuticals in Cambridge, Massachusetts

Job Description:

Quality Control Analyst II - Microbiology

Overview

Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality, and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including five programs in late-stage development. Alnylam currently has two commercial RNAi therapeutic products. The first product is approved in the U.S., EU, Canada, Japan, and Switzerland for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults and the second product is approved in the U.S. for the treatment of adults with acute hepatic porphyria (AHP). Alnylam also has a deep pipeline of investigational medicines, including five product candidates that are in late-stage development. Headquartered in Cambridge, Mass., Alnylam employs over 1,300 people in 18 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 five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2019 and Science Magazine's #1 Top Employer in 2019. Please visit www.alnylam.com for more information.

The Quality Control Analyst II- Microbiology, 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.

Summary of 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 and excursion investigations.
• Ensures continuous GMP-compliant state of the laboratory.
• Author and review technical documentation (e.g. SOPs, protocols, reports).
• Assist in deviation investigation, corrective action implementation, method improvements.
• Demonstrated technical ability in interpretation of compendia (USP, Ph. EUR, JP, etc.), and 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. Analytical Chemistry, Biochemistry, Chemistry, Biology, etc.).
• Minimum experience required for this position is 2-4 years of experience in a GMP laboratory.
• Ability to travel between domestic sites (Norton, MA; Cambridge, MA).
• Experience performing EM and CU sampling and testing.
• Experience 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.

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