Development Scientist I, Bioanalytical Development
Alexion is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in nearly 50 countries for the treatment of PNH, and in the United States, European Union, Japan and other countries for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates across multiple therapeutic areas. Further information about Alexion Pharmaceuticals, Inc. can be found at:www.alexionpharma.com.
Position Summary
Development scientist I is able to plan, design, execute, and analyze all own work independently; able to complete assigned projects and self-identify projects; able to multi-task projects, assist in prioritization and allocating effort accordingly. The incumbent is able to solve complex problems, take initiatives, identifies creative solutions, have scientific curiosity and deep understanding of relevant science. In addition, the incumbent is able to communicate cross groups and within cross functional teams, has persuasive writing and oral communication skills. The incumbent closely collaborate with R&D, clinical, and non-clinical colleagues to fulfill bioanalysis for clinical, non-clinical and R&D studies.
Principal Responsibilities
Engage in development and research projects independently, perform relevant testing/assays
Engage in assay development and validation activities
Perform relevant testing/assays and documentation for clinical and non-clinical study samples under GLP regulation; make detailed observations and documentation
Performs development and/or research in collaboration with others independently
Support other departments with testing and assay development as needed
Perform LIMS and LIMS associated activities regarding sample, reagent and data inventory and tracking when it is needed
Investigates, creates and develops new methods and technologies for project advancement independently
Train employees on relevant laboratory techniques, SOPs, etc. as needed
Maintains high level of professional expertise through familiarity with scientific literature
Use professional concept and company’s policies and procedures to solve complex problems in creative and effective ways
Able to demonstrate potential for technical proficiency, scientific creativity, and collaboration with others and independent thought. Able to work on problems independently in which analysis of situation or data requires a review of identifiable factors. Excises judgment within defined procedures and practices to determine appropriate action
Principal bioanalytical investigator or study director for non-clinical and clinical studies
May participate in scientific conferences and contribute to scientific journals
Adhere to GLP/GCP guidelines
Operate all basic laboratory equipment and complex instruments
Maintain laboratory and laboratory equipment/instrumentation. Order laboratory supplies/equipment as needed
Qualifications
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 8-11+ years of experience; BS degree relevant biological field with a minimum of 11+ years of experience
Good understanding of bioanalytical assay development, validation, and associated data analysis
Working knowledge of regulatory guidance documents that pertain to the bioanalytical discipline
Good writing and oral communication skills
Hands-on bench experiments and data analyses
Independently plan, design, execute and analyze all own work
Contribute to assigned projects, and able to self-identify projects
Able to multi-task projects, and prioritizes and allocates effort
Can solve complex problems
Take initiatives and identify creative solutions
Good writing and oral communication skills
Proficient in the use of Microsoft Word, Excel and PowerPoint
Education
Ph.D., MS or BS degree in relevant biological science field
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.