Shire Scientist in Cambridge, Massachusetts
% of Time
Perform/supervise development, characterization, validation of high complexity bioanalytical test methods.
Schedules/executes technical work (internal/external), analyzes/interprets data and generates reports.
Communications with external vendors/CROs
Assesses results and progress relative to objectives across projects and communicates periodically/as needed to supervisor and key stakeholders within group.
Performs data-level technical and quality review of assay results and implications/interpretation to ensure technical/scientific data integrity and adherence to compliance with appropriate regulatory standards.
Education and Experience Requirements
5+ years of industry related experience (BS / MS) or PhD with post-doctoral experience preferred.
Experience developing and validating (GLP) analytical and/or bioanalytical test methods required.
Familiarity and experience with global regulatory guidelines is required, eg, FDA Good Laboratory Practices (GLP)
Experience in a regulated (GLP/GCP/CLIA) laboratory environment is required.
Experience working with CROs is highly preferred.
Key Skills, Abilities, and Competencies
Excellent organizational skills and attention to detail is essential.
Excellent written and oral communication skills are required.
Broad knowledge of the theory of operation and application of advanced bioanalytical assay methods/platforms is required (ie, enzymatic, immunochemical, chromatographic, radiometric, mass spectrometric, ECL, PCR, SPR, etc.).
Experience with development, validation and/or performance of bioanalytical assay methods in a regulated (GLP/GCP/CLIA) environment is required.
Cross/inter-departmental representation experience, eg, on project teams, is highly preferred.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.