BioAnalytical Operations Lead Job @ Shire USA: 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.
BioAnalytical Operations Lead Job @ Shire USA
Posting Title: Bioanalytical & Biomarker Development Operations Lead (Assoc Director level)
Employee Type: Regular
Job Id: 16115BR
Level: ASSC DIR
Function: R & D Search
Location(s): United States – MA – Lexington
Job Category: Compliance, Research and Development, Biosciences
- Establish requirements and provide technical, quality, compliance and administrative leadership and oversight of all aspects of initiation, execution and finalization of outsourced bioanalytical and biomarker projects, including tracking and management of all BD projects using PIMS. Serve as a contact to facilitate communication with the external CRO’s to support all bioanalysis projects for rare disease programs in a variety of therapeutic indications.
- Provide hands-on implementation of industry best practices for regulated bioanalytical and biomarker studies. Provide various support functions in Laboratory Operations group for overall BBD program progression. Works collaboratively with internal groups to support BBD infrastructure such as sample storage, freezer upgrades, identification and inventory of samples to external storage facility, critical reagent supply and stability, equipment calibration and PM, maintenance and training of LIMS.
- Effectively communicate and interface with internal/external business partners, including internal Compliance, Quality Assurance and Regulatory functions to ensure that all study related methods, validations and supporting documentation (e.g. SOPs, reports) are in compliance with applicable GLP, CLIA, GCP, FDA, and other global regulatory requirement as required. Generate and review SOPs as needed. Manage QC/review of reports and data sets from both internal and CROs, including sample management of test article, tissues, etc.
- Manage finance/contracts/SOWs for the BBD group, providing support and coverage for all BBD staff.
- Generate purchase orders, process invoices for payment, account for departmental monthly spending and accruals for finance, and maintain a Master Vendor/CRO database for qualified/active vendors.
Administrative oversight and management of outsourced study placement at approved CROs while working with Shire Lead scientist to develop appropriate study design, implementation of studies, monitor study activities and data and ensure proper finalization of closeout activities and archiving. Entry of project status/progresses into PIMS for active project management.
Administrative oversight and management of group finances (PO requisitions, approving invoices, vendor management, track timelines of studies and milestone payments).
Ensure alignment of Shire internal Compliance/Quality Assurance Units and corresponding functions at CROs during all phases of regulated bioanalytical and biomarker work.
Oversee sample and critical reagent management for BBD group and support for all general BBD laboratory operations.
Collaborate with Legal Affairs and Global Procurement to ensure that all appropriate vendor contracts (MSAs, SOWs, RSAs, etc.) are created and are in place, and maintained as active. Collaborate to try and leverage vendor discounts where possible.
Education & Experience Requirements:
- Required BS in a relevant scientific discipline, 10+ years industry experience in the pharmaceutical/biotech industry and/or CRO, as well as thorough understanding of relevant regulatory guidelines (e.g. GLP, CLIA, FDA, USDA, OECD) addressing bioanalytical and biomarker support for both nonclinical and clinical studies and associated activities.
- Experience in placing and managing external work at CROs or CMOs is preferred.
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.
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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.
BioAnalytical Operations Lead Job @ Shire USA
View Original Notification: https://www.shire.com/careers/open-positions/job-detail?jd=16115br