Alnylam Pharmaceuticals
Manager, Quality Assurance (Finance)
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 Manager of Quality Assurance will work within a phase appropriate system to provide quality oversight for clinical manufacturing and supply chain activities for clinical trial material.
The position's responsibilities span early stage activities from Drug Candidate (DC) selection up to program transfer to late stage (validation and commercial) manufacturing. Key responsibilities include support of outsourced GMP manufacturing for all stages of Clinical Trial Material (CTM), review of batch documentation and disposition of CTM, assessment and, if necessary, escalation of exceptions potentially impacting clinical supply, assessment of change controls, support of Alliance Partners on quality operations activities, management of internal metrics, and support of internal continuous improvement projects.
This position reports to Associate Director Quality Assurance.
Summary of Key Responsibilities
Qualifications
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.