This Development Associate IV will be a key team member in Alexion's analytical technology transfer and technical group to support internal and external QC testing facilities for clinical programs. This position will work closely with the GMP testing laboratory (both internal and external) in supporting data management activities and providing scientific feedback regarding assay performance, especially to method development group. This position will manage all the data summary, data trending and generate related technical report. This position will also ensure the data integrity per regulatory requirements.
Works closely with department roles and cross-functional study team members to create reporting and analytics solutions that support the quality and timely delivery of data management reports and visualizations required per SOP and study specific data review plans.
Creates any needed documentation for reports throughout the lifespan of the study and or asset for all deliverables such as data trending development report, CoA/CoT for external lab testing.
Complies with applicable SOPs and work practices. Draft and revise SOPs related to data management.
Serves as lead as for data management. Provide sound scientific feedback on assay performance based on data collection/trending and understanding of testing assays
Serve as a technical resource to the study teams for data trending for assay performance, data visualization, and reporting tools
Ensure operational excellence in collaboration with partners and colleagues for application of standards and develop data cleaning reports in support of the data review plan, in collaboration with testing and method development group, ensure operational excellence across all requested deliverables
Directly supports knowledge development of others on reporting and analytics tools that support assay performance and the accuracy/ integrity of study data
Bachelor's degree in Statistics, Biostatistics, Biology, chemistry or related field with a minimum of 10 years relevant experience in a pharmaceutical, biotech, CRO, or Regulator Agency with an emphasis on building reporting and analytics solutions or Master's degree with 7 years relevant experience.
GMP experience in analytical testing and familiarization with testing assays are preferred
Understanding of drug development process, batch release testing and data operations required for the reporting in variety of format (e.g. data review, date trending for assay performance, study reports, regulatory submissions, etc.)
Understanding of regulatory requirements such as data integrality and data trending
Strong communication (written and oral), decision-making, influencing, negotiation, and project management skills
Technical skills and experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview)
Experience in JMP, Oracle, PL/SQL, SAS, Java, relational database design and database programming skills
Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
Experience in gLIMS system is preferred
Knowledge of method validation and transfer is a plus
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.