ALNYLAM PHARMACEUTICALS INC Analytical Sciences Lead, Contract Testing Salary in the United States

Analytical Sciences Lead, Contract Testing   Overview Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need. Our first medicine, the first-ever RNAi therapeutic, has recently been approved by the FDA in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition, Alnylam has four investigational medicines in late-stage development.  www.alnylam.com.  Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work in 2015, 2016, 2017 and 2018- four years in a row! The Analytical Sciences Lead will be responsible for the support and oversight of the outsourced analytical GMP/GxP activities (CMOs and CTLs) for Alnylam’s pipeline of early stage clinical technology transfer work through feasibility, method validation, routine release, and stability testing. Summary of Key Responsibilities - Support outsourced GMP/GxP release and stability programs. - Facilitate and Support Document review and exchanges between business partners, Alnylam and CMO/CTLs. - Act as a liason to drive external analytical quality events such as Out of Trend (OOT), Out of Specification (OOS) investigations, deviations, CAPA and Change controls with feedback from Internal EA and QA. - Perform data review and technical review of SOPs, protocols and reports. - Assist with analytical technology transfer and feasibility, method validation, and routine release and stability testing at CMO and CTL vendors.  - Assist with and/or author technical documentation (e.g. SOPs) with appropriate level of guidance, when needed - Assist with drafting and data verification of characterization, analytical, and stability sections of regulatory submissions. - Act as a liaison to facilitate transfer technical expertise, trouble shoot and perform assay development to support internal and external analytical development and quality control. - Support and facilitate Data Review and Generation of Certificates of Analysis.  - Assist in standards/sample shipment and associated paperwork for external labs to support GxP activities - Must be a team player, self-starter and open to change. - Attention to detail is a must. - Must be highly organized. - Must have excellent communication and public speaking skills. Can make presentations on validation and release/stability activities. - Some travel required, up to 10%. - On time and compliant completion of external method qualification to support lot release.  - Timely delivery of outsourced GLP/GMP release and stability results. - Significant contributions to Analytical Science department / Alnylam goals and objectives. Qualifications - B.S. or M.S. in applicable science field; chemistry preferred. - 4+ years of experience in Quality Control / GMP laboratories is required. - Established background in technical QC and GMP experience. - Experience with vendor management of CMOs and/or CTLs programs is strongly preferred. - Ability to work independently and in compliance with cGMPs. - Expertise in ICH guidelines, USP/EP/JP - Excellent team skills, organization, and strong communication skills - Must be able to lift and move heavy objects. - Must be able to stand for prolonged periods of time. - Must be able to adhere to all laboratory safety requirements Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.   #LI-TS1