Primary Duties: * Responsible for researching/designing and managing a broad range of bioanalytical and biomarker method development, validation, sample testing, as well as data interpretation and reporting. * Recognized as having advanced expertise in their field of training and broad knowledge of drug discovery; applies independent judgment and direction to design, execution, and interpretation of experiments in compliance with appropriate global regulatory guidance. * Manage or lead projects for multiple programs across the portfolio and schedules activities in accordance with line function and program/corporate goals/assignments and priorities supporting Discovery, Nonclinical and Clinical programs. * Effectively manage both internal and external work, including interactions with technical and administrative staff at CROs or external vendors to deliver high quality results in a fast-paced environment. * Implement innovative approaches and proposes new strategies within Research; develops new methods and extends technology to drive applied science into new application areas. * Act as a resource or provide guidance to colleagues. * Author or contribute to Clinical Study Report sections, regulatory documents and abstracts/manuscripts for publication. Review assay validation and bioanalytical reports and provide training and mentorship to internal staff. Responsibilities: 50% Research/identify/design and implement high complexity bioanalytical test methods and/or biomarker strategies. 10% Manage external vendors/CROs to meeting sample testing timelines 10% Performs high-level review of assay results/interpretation/reports to ensure technical excellence and compliance with appropriate regulatory standards. 10% Assesses progress relative to objectives and communicates progress periodically to supervisor and key stakeholders within and outside Group. 10% Represent Bioanalytical group in various project team meetings 10% Author or contribute to Clinical Study Report sections, regulatory documents and abstracts/manuscripts for publication. Education and Experience Requirements: * PhD in life science (preferentially immunology) with more than 8+ years of industry experience. * Experience in leading biological molecule PK and biodistribution as well as ADA, biomarker studies in various matrices (serum, CSF, urine) and tissues (brain, spinal cord, liver, kidney, spleen, lymph nodes) to support both non-clinical and clinical studies. * Familiarity and experience with global regulatory guidelines, expectations and corresponding industry best practices is required, e.g., FDA Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP). * Experience in placing and managing external work at CROs/CMOs is required. Key Skills, Abilities, and Competencies: * Expertise on development, validation and performance of bioanalytical assay methods in a regulated Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP) environment is required. * Broad knowledge of the theory of operation and application of advanced bioanalytical assay methods/platforms is required (i.e., enzymatic, immunochemical, chromatographic, radiometric, mass spectrometric, ECL, PCR, SPR, etc.). * Expertise on exploratory biomarker studies including qualification, validation and sample testing in a GLP/CLIA environment * Expertise on RNA and DNA analysis using state of art molecular biology techniques is preferred * Excellent management and organizational skills, and attention to detail, are essential. * Candidate must be highly independent and motivated, has excellent oral and written communication skills and ability to deliver results in a fast paced environment. * Cross/inter-departmental representation experience, e.g., on project teams, is highly preferred. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.