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Form of workJob Description: BioAnalytical Sciences Operations translates and applies strategy and innovation for bioanalysis and immunogenicity into clinical and non-clinical studies through global collaboration and robust CRO portfolio management. Our team brings technical and operational expertise along with passion and drive to make a difference for patients. The Scientist 3 will support the development portfolio by providing technical oversight of clinical and non-clinical bioanalytical methods including validation and lifecycle management of Ligand Binding Assays supporting pharmacokinetic, toxicokinetic, pharmacodynamic, and biomarker analyses outsourced to Contract Research Organizations (CRO).
The Scientist 3 will also review bioanalytical clinical and non-clinical method performance data generated at the CROs. The Scientist 3 will support the Genentech portfolio by: Serving as the front-line technical contact with CROs for routine outsourcing activities in support of method qualifications and validations (Ligand Binding Assays and new technologies) and any technical questions that arise around assay performance or lifecycle management during the course of clinical, non-clinical study assay performance. Providing technical oversight of outsourced methods (Ligand Binding and new technologies), ensuring qualified/validated state for optimal assay quality: Technical review of assay data from development, feasibility, qualification/validation, assay performance from clinical/non-clinical sample analysis.
Technical review plans (qualification/validation/sample analysis), reports (qualification/validation/sample analysis) Technical support during assay troubleshooting and lifecycle management Proprietary Critical Reagents (Reference standards, MAbs, ligands): forecasting, requesting new material, shipping, re-test date extension. Supplemental validations to support additional matrices, disease states, co-medications, critical reagent incorporation, Coordinate assay transfers to multiple CROs and subsequent Technical support of cross validation experiments between CROs. Generate internal technical reports: validation history, cross validation, or memorandum Share with internal key stakeholders assay data (transfer, feasibility, qualification, validation, troubleshooting, assay performance) and documents (methods, plans, reports, memorandum).
May Lead technical teleconferences with CROs and attend internal bioanalytical working group meetings. This individual will work in a fast-paced and highly collaborative team based environment. S/he will be asked to present at bioanalytical working groups or all staff meetings and to prepare poster presentations.
S/he may train others on group responsibilities and systems. S/he may also be responsible for implementation or maintenance of support systems and may lead department teams charged with improving business processes. Qualifications: Bachelor's or Master's degree in Bioanalytical Sciences, Analytical Chemistry, Biochemistry or equivalent experience 3-8 years in industry and/or testing laboratory (Clinical, non-clinical, or CRO).
Familiarity with bioanalytical method GxP compliance is required. The Scientist 2 or 3 may have a technical background in developing, validating, implementing, maintaining, and troubleshooting quantitative assays as well as have demonstrated problem solving abilities of bioanalytical methods in: LC-MS This is the pay range that Magnit reasonably expects to pay for this position: $45.00/hour-$61.24/hour Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met) Magnit has an ongoing commitment to the diversity and inclusion of all team members. We believe that embracing diversity leads to innovation and helps address the needs of the business.
We welcome individuals from different backgrounds, experiences, and cultures to join our team. We value this diversity and strive to create an inclusive environment that celebrates these unique perspectives, allowing you to contribute to your full potential. Finally, but most importantly, we expect all team members to be treated with dignity and respect.
If you have a disability and need an accommodation in relation to the online application process, please email us at Roche.Accommodations@magnitglobal.com
