• Provide strong technical, quality and compliance leadership of all aspects of initiation, execution and finalization of outsourced bioanalytical projects at Shire. Support nonclinical, clinical and post-market surveillance studies for Shire programs in a variety of therapeutic indications.
• Provide leadership in the implementation of industry best practices for bioanalytical studies. Oversee and provide technical and compliance insights for assay transfers, method development and validations, study sample analysis and data reporting and Serve as the key contact with external contract research organizations (CROs) for assigned projects.
• Effectively communicate and interface with internal/external business partners, including internal Compliance and Quality Assurance Units functions to ensure that all methods, validations and supporting reports are in compliance with applicable regulatory requirements as required.
• Working with Shire Legal Affairs, Compliance and Quality Assurance Units and corresponding functions at CROs performing validation and sample analysis work for the Nonclinical Development and Clinical Development. Manage QC/review of data and reports from CROs, including sample management and disposal.
Manage bioanalytical studies at CROs for assigned projects. Plan and design bioanalytical studies. Review and approve study plans/protocols. Oversee bioanalytical method development, validation and sample analysis. Provide guidance, troubleshoot problems, and make decisions to ensure data quality and timelines in support of non-clinical and clinical programs. Working together with bioanalytical CROs, the data management CROs and Shire Data Management managers, ensure the bioanalytical data are transferred with accuracy and within the agreed timelines. Review, edit, and approve bioanalytical study reports.
Participate in non-clinical and clinical study design and planning, responsible for bioanalytical sections in DMPK, toxicology and clinical study protocols. Contribute to nonclinical main study reports and clinical study reports (CSRs). Write bioanalytical method validation and sample analysis sections for regulatory submission documents.
Assess, select, and approve bioanalytical CROs. Working with Shire Operations, Procurement and Legal colleagues, facilitate CDAs/MSAs with vendors. Initiate, negotiate, and approve CRO quotations/statement of works for Shire bioanalytical studies. Manage program budgets. Working with Operation's team, set up purchase orders and review/approve invoices
Working closely with colleagues in Project Management, NCD (Toxicology, Pharmacology, DMPK and BBD), Clinical Operations, Clinical Pharmacology, Biometrics, Biostatistics, Regulatory Affairs, and Commercial groups, prioritize bioanalytical work to ensure deliverables in-line with company timelines and milestones.
Play a key role in resolving QA audit findings and responsible for providing responses to regulatory authorities regarding bioanalytical related inspection findings and regulatory questions for assigned projects.
Education & Experience Requirements:
• PhD or MSc in chemistry or related subject
• 10+ years of experience in quantitative bioanalysis working with the pharmaceutical/biotech industry
• Strong background in LC-MS/MS based method development and sample analysis for plasma and tissues
• Broad experience from preclinical and clinical drug development
• Significant experience in a regulated laboratory environment
• Knowledge of and experience with global regulatory guidelines, expectations and corresponding industry best practices
• Experience in placing and managing external work at CROs
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.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy
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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.