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 #J-18808-Ljbffr Alnylam