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Quality Control Analyst II - Raw Materials

Company: Alnylam
Location: Cambridge
Posted on: August 5, 2022

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 for more information. The Quality Control Analyst II will be primarily responsible for routine sampling, inspection and testing of incoming raw materials in support of GMP manufacturing at the Alnylam - Alewife facility, 665 Concord Avenue, Cambridge, MA with secondary support for Norton facility, 20 Commerce Way. Additional responsibility supporting routine analytical testing of in-process and bulk drug product materials. Demonstrated technical ability in QC analytical, ability to interpret compendia (USP, Ph. EUR, JP, etc.), and troubleshooting experience are required; and microbiological methodology understanding is desirable. This position requires flexibility with changing priorities. Summary of Key Responsibilities Supporting the raw material program at the GMP manufacturing site at the Alnylam facilities. This includes inspection of raw material components, sampling of materials, drug substance and chemicals within a cleanroom and at an offsite storage facility. Performance of QC raw material, in-process, and bulk drug product testing, as well as support of testing/review of data with/from contract testing laboratories (e.g. compendial methods, HPLC, fluorescence assays, particle sizing, etc). Author technical documentation (e.g. SOPs, specifications and risk assessments). Troubleshoot routine problems related to laboratory procedures, assay performance, instrumentation, and data with input from Supervisor; provide recommendations to non-routine issues. Support operational systems (e.g. equipment maintenance, reagent preparation, forms control, etc.). C ollaborate with other internal departments efficiently and effectively (e.g. Manufacturing, Warehousing, Facilities, QA, etc. Demonstrated technical ability in QC analytical, ability to interpret compendia (USP, Ph. EUR, JP, etc.), and troubleshooting experience are required; and microbiological methodology understanding is desirable. Secondary support for the Raw Material program including: Performing Environmental Monitoring within a cleanroom Performing critical utility sampling of water and compressed gas. 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 years of relative experience in a GMP laboratory. Must demonstrate competency with laboratory skills, including documentation. Ability to travel between domestic sites (Cambridge, MA; Norton, MA; and Franklin, MA) Familiarity of compendial requirements (USP, Ph. EUR, and JP) Familiarity or experience with raw material sampling and release Familiarity or experience in Analytical Chemistry and/or microbiology is desirable 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.

Keywords: Alnylam, Cambridge , Quality Control Analyst II - Raw Materials, Professions , Cambridge, Massachusetts

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