Quality Control Analyst I

Quality Control Analyst I

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 I- Microbiology will be primarily responsible for performing routine environmental monitoring (EM), critical utility (CU) sampling, and testing of in-process and bulk drug product materials 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. Demonstrated technical ability in QC microbiology and understanding of microbiological methodology is required; ability to interpret compendia (USP, Ph. EUR, JP, etc.), and troubleshooting experience is desirable. This position requires flexibility with changing priorities.

Summary of Key Responsibilities

• Supporting the EM/CU program at the Norton (primarily) and Alewife GMP manufacturing facilities.
• Perform EM and CU sampling within a new cleanroom facility.
• Perform QC testing (i.e., viable air, total particulate, Total Organic Carbon (TOC), conductivity, bioburden, endotoxin).
• Perform microbial counting and identification using MALDI-TOF.
• Ensures continuous GMP-compliant state of the laboratory.
• Author technical documentation (e.g., SOPs, protocols, reports).
• Troubleshoot routine problems related to laboratory procedures, assay performance, instrumentation, and data with input from Supervisor; provide recommendations to non-routine issues.
• Assist in deviation investigation, corrective action implementation, method improvements.
• Support operational systems (e.g., equipment maintenance, reagent preparation, forms control, etc.).
• Collaborate with other internal departments efficiently and effectively (e.g., Manufacturing, Warehousing, Facilities, QA, etc.)
• Demonstrated understanding of microbiology methodology and technical ability in QC microbiology are required; ability to interpret compendia (USP, Ph. EUR, JP, etc.), and troubleshooting experience are desired.
• 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 0 – 2 years of relative experience in a GMP laboratory. Must demonstrate competency with laboratory skills, including good documentation practices (GDP).
• Ability to travel between domestic sites (Norton, MA, Cambridge, MA)
• Familiarity with performing EM and CU sampling and testing.
• Familiarity with Compressed Gas and Water for Injection Systems.
• Familiarity or experience with standard microbiology testing (Bioburden, TOC, Conductivity, Endotoxin)
• Familiarity in raw material sampling and analytical testing is desirable.
• Familiarity of compendial requirements (USP, Ph. EUR, and JP).
• If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required.

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