The Scientist I will spend approximately 50% of work time in lab and 50% in office-based work.
The incumbent is expected to be involved in the design, development, validation, and execution of bioanalytical assays for small and large molecules in a regulated environment.
The incumbent is expected to independently develop and validate methods for regulated assays and develop and qualify fit-for-purpose bioanalytical assays for Alexion therapeutics at various stages of discovery and development.
The incumbent will be focused on innovative approaches in method development, such as DOE and lab automation.
In addition, the incumbent is expected to communicate cross groups and within cross functional teams, has persuasive writing and oral communication skills.
The incumbent will closely collaborate with R&D, clinical, and non-clinical colleagues to fulfill bioanalysis for clinical, non-clinical and R&D studies.
You will be responsible for:
Function as a subject matter expert in the area of bioanalytical method development
Drive the bioanalytical innovation by improving the quality and efficiency of method development and lab operation
Serve as part of the BA sub-team, working with Bioanalytical project lead to support discovery or development projects for method qualification/validation, data reporting, and interpretation of issues associated with the bioanalytical results
Transfer qualified and fit-for-purpose assays to CROs and serve as the primary point of contact for assay transfer and troubleshooting of technical assay issues within project specified timelines
Integrate quality standards to ensure that bioanalytical data is fit-for-purpose (e.g. GLP compliance at CROs for regulated analyses)
You will need to have:
Ph.D. in a relevant scientific field with a minimum of 0-3 years of biotechnology-related experience (may include post-doctoral experience); MS degree in relevant biological science field with a minimum of 8 years of experience; BS degree relevant biological field with a minimum of 11 years of experience
Experience with immunoanalytical methods, LCMS based methods and cell culture technique based assays for discovery support
Experience performing method development using Design of Experiments (DOE) and lab automation
Experience in organizing and managing multiple bioanalytical projects in the laboratory setting
Well organized, motivated, team player, and works with a sense of urgency
Experience in transferring assays to CROs, monitoring development/validation, and sample analysis
We would prefer for you to have:
Experience in developing and validating bioanalytical assay in a regulated environment
Experience in regulatory submission, e.g. NDA, BLA and interactions with health agencies
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
