Shire Senior Scientist BBD (Large Molecule PK/PD/Immunogenicity in Lexington, Massachusetts
Responsible for managing and/or performing a broad range of bioanalytical and biomarker method development, validation, sample testing as well as data interpretation and reporting to support Research, Non-clinical, Clinical and Commercial Development programs for rare diseases in a variety of therapeutic indications.
Recognized expertise in his/her field of training and broad knowledge of drug discovery and development with ability to apply independent judgment and direction in design, execution, and interpretation of experiments in compliance with appropriate SOPs and global regulatory guidance.
Must have demonstrated success managing multiple priorities with aggressive timelines providing technical, planning, budget and resource oversight. Handles projects for multiple programs across the portfolio and schedules activities in accordance with line function and program/corporate goals/assignments and priorities. Must be highly independent and motivated with excellent oral and written communication skills.
Effectively manages 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.
Knowledge of and experience with global regulatory guidelines, expectations and corresponding industry best practices required.
Responsibilities (% of time):
Manage and/or perform development, characterization, validation, outsourcing and administration of high complexity bioanalytical test methods.
Schedule/execute technical work (internal/external), analyze/interpret data and generate reports
Management of and communications with external vendors/CROs
Assess results and progress relative to objectives and communicate progress periodically/as needed to supervisor and key stakeholders within and outside the group.
Perform high-level quality review of assay results and implications/interpretation to ensure technical/scientific data integrity/excellence and adherence to compliance with appropriate regulatory standards.
MS in life sciences with 8+ years of industry experience or PhD in life sciences with 5+ years of industry experience.
Experience developing and validating GLP/GMP analytical and/or bioanalytical test methods for small and large molecules.
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 a regulated (GLP/GCP/GMP/CLIA) laboratory environment is required.
Experience placing and managing external work at CROs/CMOs is required
Key Skills, Abilities & Compentencies:
Experience in performing biological molecule PK and bio-distribution and 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.
Broad knowledge of the theory of operations and application of advanced bioanalytical assay methods/platforms is required (i.e., enzymatic, immunochemical, chromatographic, radiometric, ECL, PCR, SPR, etc.).
Experience in immunogenicity assessments and relevant regulatory requirements for large molecules required.
Experience in quantitative analysis of lipids, oligosaccharides, and peptides/proteins in biological matrices using LC-MS/MS platform and expertise in mass spectrometric assays to support ADME studies, e.g., detecting analytes, metabolites and biomarkers in matrices and tissues may be required for specific positions.
Expertise in exploratory biomarker studies including qualification, validation, and sample testing in a GLP/CLIA environment.
Expertise on RNA and DNA analysis using state of the art molecular biology techniques is preferred.
Cross/inter-departmental representation experience, e.g., on project teams is highly preferred.
Equal Employment Opportunity
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 committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
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.