Principal Associate Scientist, Analytical Sciences

NOTICE OF FILING AN APPLICATION FOR PERMANENT EMPLOYMENT CERTIFICATION JOB TITLE: Principal Associate Scientist (Multiple Positions) JOB DUTIES: Perform analytical testing of siRNA drug substances, drug products, and critical raw materials. Author and review stability protocols, reports, and SOPs. Contribute to the design and execute special use stability using sound DoE principles. Studies include freeze-thaw, thermal cycling, compatibility with intended injection device, and in-use studies. Support outsourced GMP/GxP stability programs for drug substance and drug product. Provide sound statistical interpretation of stability data, and their relation to release and lifetime specifications. Contribute data to characterization, analytical, and stability sections of regulatory submissions. Assist with responses to agency requests on these sections. Contribute to investigations of stability Out of Trend (OOT) results. Contribute as owner of Change Controls and CAPA. Provide stability expertise to the assessment of temperature excursions. MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS: Master’s degree in Engineering (any), Analytics (any), Chemistry, Pharmacy or Biochemistry or related field of study and four (4) years of experience in the job offered or related occupation in which the required experience was gained. In lieu of a Master’s degree in Engineering (any), Analytics (any), Chemistry, Pharmacy or Biochemistry or related field of study and four (4) years of experience, the employer will also accept a Bachelor’s degree in Engineering (any), Analytics (any), Chemistry, Pharmacy or Biochemistry or related field of study and seven (7) years of experience in the job offered or related occupation in which the required experience was gained. Must have demonstrated experience with: Analytical Instruments and Techniques (HPLC, UPLC, US spectroscopy or pH); analytical data review, interpretations, and trending; statistical analysis of data and interpretations; Investigations, Deviations and Change Controls; stability studies designed and conducted in accordance with ICH stability guidelines; technical writing; and analytical laboratory environment (cGMP). OTHER: Employer: Alnylam US, Inc. Job location: 675 W Kendall Street, Cambridge, MA 02142 40 hours/week; $110,550.00 - $138,000.00/Year (view contact information below) If offered employment must have legal right to work in U.S. EOE. This notice is being posted as a result of the filing for a permanent resident labor certification application for this job opportunity. Any person may provide documentary evidence bearing on the application to: U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210 CONTACT: To apply, submit a resume to https://jobs.alnylam.com/careers?start=0&pid=893380660936&sort_by=hot, OR submit a resume to https://jobquest.dcs.eol.mass.gov/jobquest/LandingPage.aspx OR mail resume to: Alnylam US, Inc., Attn: HR, 675 West Kendall Street, Cambridge, MA 02142. Must reference Job Title & Job Code: [Requisition Number provided by Alnylam]. EOE. About Alnylam We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer. Before applying, please review Alnylam's ⁠Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment. The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers U.S. Pay Range $102,000—$138,000 USD

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