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Shire Scientist, Bioanalytical & Biomarker Development in Cambridge, Massachusetts
We are seeking a highly motivated scientist to join our Bioanalytical and Biomarker Development (BBD) department at Shire. Reporting to Associate Director, the individual will implement bioanalytical and biomarker strategy and design/develop/validate/execute LC-MS assays in support of different stages of drug development programs for both small and large molecule modalities.
Work with project teams and BBD colleagues to develop bioanalytical and biomarker strategies to support new and ongoing nonclinical and clinical programs in Hereditary Angioedema (HAE) therapeutic area.
Responsible for designing, developing, validating, and implementing Dried-blood spot (DBS)-based assays for the diagnosis of HAE.
Develop a wide range of regulated (GLP, GCLP) LC-MS assays in biological matrices (plasma, serum, CSF, urine) and subsequent sample testing in support of both small molecule and biotherapeutics pipelines.
Represent BBD to interact with cross-functional teams (discovery, DMPK, pharmacology, toxicity, biostatistics, clinical development, etc.) and meet project goals and timelines. Articulate and communicate key bioanalytical concepts to various stakeholders.
Work closely with study management group in BBD to manage bioanalytical and biomarker assays at CRO labs, oversee the validation and sample testing, review validation and sample analysis protocol and assay reports to ensure data quality and regulatory compliance, interpret bioanalytical data, troubleshoot technical issues, etc.
Manage a bioanalytical lab equipped with state-of-the-art LC-MS and other associated instruments (e.g. HRMS, TOF, QTrap and QqQ MS).
Maintain a current knowledge of latest technological, scientific trends, and regulatory expectations.
Implement or apply innovative techniques to solve the challenging bioanalytical issues.
Authoring study reports and manuscripts and presenting scientific data to project teams. Contribute to clinical study reports and other regulatory documents.
Responsibilities (% of time):
Design strategy and develop high complexity bioanalytical assays to support dried-blood spot (DBS)-based HAE diagnosis. Develop LC-MS assays for clinical PK and biomarker studies of both small and large molecule programs.
Manage assay transfer, validation, and sample testing in CROs. Provide regulatory guidance, troubleshoot technical problems, and perform high-level review of assay results/interpretation/reports to ensure technical excellence and compliance with appropriate regulatory standards.
Assess progress relative to objectives and communicates progress periodically to supervisor and key stakeholders within and outside Group.
Represent LC-MS and BBD group in various project team meetings
Ph.D in the field of biochemistry, chemistry, or molecular biology with at least 2 years of postdoc experience in LC-MS related fields, or a MS degree with at least 6-8 years of industry experience in regulated bioanalysis using LC-MS platform.
In-depth knowledge of global regulatory guidelines, expectations and corresponding industry’s best practices for bioanalytical assay development and validation is required.
Hands-on experience with LC-MS instruments and their applications (proteomics, protein quantitation, small molecule quantitation, etc.) is a must.
Excellent communication, collaboration, and organization skills and the ability to work in a fast-paced and dynamic team environment are essential.
Must be goal-oriented, quality-conscientious, and team-focused
Experience in large data analysis for biomarker, target, disease pathway, or drug mechanism of action studies is a plus.
Experience working with a laboratory information system to manage data and results is a plus.
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Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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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.