Manager, Bioanalytical Operations
- Palo Alto, California; Philadelphia, Pennsylvania; Remote Non Sales-USA, California
- Research & Development
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
The Manager, Bioanalytical Operations will work with clinical and nonclinical study teams, bioanalytical contract labs, central labs, and sample storage/archival facilities to manage the storage, shipment, and analysis of biological samples in pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity assays. The candidate will also assist clinical study teams to ensure that bioanalytical considerations are incorporated into lab manuals, study protocols, and study timelines.
Essential Job Functions:
- Oversee the shipment and receipt of biological samples from central labs and clinical sites to bioanalytical labs
- Ensure project timelines for sample analysis and data transfers are maintained. Provide updates and escalate issues to study teams, as needed
- Coordinate transfer of reference standards and other reagents to bioanalytical labs and ensure that certificate of analysis and other supporting documentation is up to date
- Assist in the preparation of the clinical Lab Manual
- Assist in the selection of bioanalytical vendors
- Participate in the oversight of bioanalytical vendors, which includes managing contracts, specifying data formats, preparing vendor oversight plans, ensuring compliance and inspection readiness of bioanalytical laboratories as governed by GLP/GCP regulation
- Manage archival of method validation and bioanalytical study reports in a document management system
- B.S. degree in a scientific field
- ≥3 years of experience working in the pharmaceutical industry
- Demonstrated knowledge of sample and data management in a clinical study setting
- Thorough understanding of requirements for method validation and sample analysis under GLP, GCP, cGMP requirements, ICH guidelines and FDA guidance
- Proven ability to manage CROs
- Excellent written and oral communication skills
- Excellent organizational and time-management skills
- Proven ability to manage multiple projects
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.