Provide technical leadership and hands-on contributions to pre-development and product development projects for Diagnostics in a team environment. This group utilizes triple-quad mass spectrometers as the detection instrument for assay development under an IVD quality system for Newborn Screening and adjacent clinical space.
Responsible for the development of robust and reliable ligand binding assays in non-clinical and clinical biological matrices suitable for characterizing of exposure and immunogenicity of biotherapeutics using a range of potential screening platforms and assay techniques.
Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
Collaboratively plan and execute in-depth analyses using techniques such as ellipsometry, DSC, TGA, FTIR, Raman, SEM, XPS, TOF-SIMS, AFM, high resolution spectroscopy and microscopy to characterize dimensions at the interface between assay chemistry and substrate materials.
In this role, the selected candidate must have strong understanding of data structures, algorithms, and design pattern; demonstrated experience in data curation, data mining and an ability to interrogate, interpret, and visualize large and diverse, biological and toxicological datasets.
Independently design, execute and interpret in vivo pharmacology experiments to characterize small molecule based drug pharmacology and mechanism of action to support projects from early discovery to clinical development.
Initiates, monitors and conducts Study Initiation and Close Out procedures at clinical study centers; inclusive of training of study site personnel, oversight of protocol adherence, data verification of source documents and accountability of all study supplies. Must be able to troubleshoot and resolve routine study conduct issues.
The successful candidate will be responsible for the design and execution of selection and screening strategies to isolate high affinity antibodies that meet criteria such as species cross-reactivity and biological function.
Designs technical strategies with and regularly reports on progress in meeting objectives to supervisor; understands and follows compliance requirements and independently refers to policies and practices for guidance.
The position will perform data analysis, including the analysis of newly produced data plus integration of large amounts of external data, with a strong focus on biological interpretation and pathway / network analysis.
Ability to work with business partners and GBS (our global business services and solutions provider) to maintain and enhance short and long-term Business Analytics strategy and roadmap designed to anticipate, understand and respond to business priorities.
Comprehensive understanding of PK and ADME principles, enzyme kinetics, IVIVE and quantitative DDI risk assessment. Strong technical in vitro assay knowledge and up-to-date best industry practices to enhance continuous DDI in vitro assay improvement and strong troubleshooting skills.