The Development Associate I is responsible for performing assigned experimental tasks to support the development and optimization of manufacturing processes or analytical/characterization methods as well as GMP stability and release testing for Alexion's bio-therapeutic candidates. The Development Associate I will work in collaboration with other members of the Global Product Development team and across other functional areas throughout Alexion.
Perform all job functions in compliance with cGXPs and maintain accurate and legible laboratory records.
Perform testing in the following areas: Plate based assays, U/HPLC applications (SEC-HPLC, peptide mapping, Pro A HPLC, Ion Exchange Chromatography, etc), spectrophotometric applications, and capillary/gel electrophoresis (IEF/iCE and SDS-PAGE/CE-SDS) with staining and densitometry for in-process, drug substance and drug product release and stability samples.
Aid in experimental studies, developing, optimizing, qualifying or supporting manufacturing processes or analytical/characterization methods for biotherapeutic candidates
Draft PRCs/SOPs, qualification and validation protocols and reports, and technical reports as assigned.
Compile data and information related to assay and instrument performance.
Recognize aberrant test and sample conditions and report to them to the area supervisor / manager.
Order, stock, and receive, label, log, and inventory laboratory supplies. Ensure proper incoming sample receipt and inventory as assigned.
Provide laboratory support services, clean/maintain equipment and prepare reagents/solutions.
Ensure training is current for all job functions performed. Attend all required company training.
Provide timely and legible laboratory notebook data or documentation.
Perform other related duties as assigned
A successful candidate will typically have 6+ months of experience working in a relevant laboratory setting
Knowledge of GMPs and their application in the environment is preferred.
Follow written procedures when conducting experiments and applying methods
Document procedures and data in peer-reviewed laboratory notebooks
Order, stock and maintain inventory of laboratory supplies
Participate in general laboratory operations including equipment maintenance and organization
Interact with Technical Operations groups, Research and external vendors
Able to organize his/her own work on a routine basis with supervision. When asked, the individual is able to provide updates and tracking on his/her tasks.
The ability to communicate verbally and in a written format is required.
Proficiency with various MS Office programs, including Word, Excel, Outlook, and PowerPoint
New Haven, CT, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
Alexion Pharmaceuticals, Inc.