Development Associate III, Bioanalytical Development

Job Description
Reports to: Development Scientist II, Bioanalytical Development
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-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. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.

Position Summary
The development associate III position resides in the bioanalytical development department, which supports the bioanalytical needs of non-clinical and clinical trials. This includes the development and validation of assays for pharmacokinetics, pharmacodynamics and anti-drug antibodies, in a regulated environment. The primary analysis platforms include LC-MS, ELISA, and MSD technologies. A major aspect of this work is diligence in documentation and compliance with current department SOPs, GLP and regulatory guidelines. There will also be an emphasis on interacting with contract research organizations (CROs). Ideally, the candidate will have experience in both large and small molecule bioanalysis.

Principal Responsibilities
•Engage in development projects leading to validation of bioanalytical assays for multiple matrices including serum, plasma and urine.
•Design and execute own routine work, using established methods, with an understanding of the timelines and how the activities fit into a larger project.
•Works on projects of routine to complex scope in which analysis of assay components, procedures or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.
•Investigate, create and develop new methods and technologies for project advancement.
•Perform relevant testing/assays and maintain detailed documentation, including electronic laboratory notebook (ELN), for clinical and non-clinical GLP studies.
•Prepare and characterize critical assay reagents.
•Serve as a technical expert on lab instrumentation, software and/or assay procedures, documentation and/or GLP study protocols.
•Maintain laboratory supplies, chemicals, lab equipment and logs.
•Perform LIMS and LIMS associated activities regarding sample, reagent and data inventory and tracking when needed.
•Adhere to GLP/GCP guidelines.
•Maintains high level of technical expertise through familiarity with scientific literature.

Qualifications
•Experience in a regulated bioanalytical environment.
•Experience working with CRO and ability to facilitate Sponsor-CRO interactions.
•Basic knowledge of LC-MS.
•Experience with ligand binding assays including ELISA and MSD.
•Highly organized and capable of handling multiple tasks/projects simultaneously.
•Excellent organizational skills and ability to prioritize tasks based on project timelines.
•Excellent verbal and written communication skills as well as technical writing.
•Strong documentation and inter-personal skills and willingness to collaborate with colleagues at the bench and on project teams.
•Familiar with standard bioanalytical laboratory instrumentation and software including MSD benchtop and Softmax PRO.
•Highly organized and capable of handling multiple tasks/projects simultaneously
•Weekly general direction from supervisor; able to execute routine work independently
•Able to perform assigned tasks
•Can solve routine problems
•Able to demonstrate lab skills and be the resource of routine lab procedures
•Good written and oral communication skills

Company

Alexion Pharmaceuticals

Job Code

State or Province

Connecticut

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