Development Scientist II, Bioanalytical Development- QC - United States
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Development scientist II is responsible for ensuring the quality of the data generated for support of GxP bioanalysis; leading experiment designs; contribute to assigned projects; able to multi-task projects, prioritizes and allocates effort; can lead cross functional problem solving; can represent group in broad R&D teams; managing a group of colleagues or a project team. The incumbent will closely collaborate with R&D, clinical, and non-clinical colleagues to fulfill bioanalysis for clinical, non-clinical and R&D studies.
- Require to have GLP laboratory experience, proficient with GLP and GCP regulations, adhere to GLP/GCP guidelines.
- Able to use professional concept and procedures to solve difficult problems in creative, practical and effective ways.
- Able to demonstrate success in technical proficiency, scientific creativity, and collaboration with others and independent thought.
- Able to work on problems of diverse scope in which analysis of situation or data requires a review of identifiable factors. Excises judgment within defined procedures and practice for obtaining solutions.
- Can lead an inter-department project or initiative involving other contributors.
- Can lead cross-functional problem solving.
- Able to communicate across groups and within cross-functional teams.
- Able to persuasive written and oral communication.
- Maintains high level of professional expertise through familiarity with scientific literature.
- Investigates, creates and develops new methods and technologies for project advancement.
- Perform relevant testing/assays for assay development, validation, bioanalysis on clinical trial samples and make detailed documentation.
- A Ph.D. with minimum of 4-8 years of relevant biological science 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 including good presentation skills
- Hands-on experience with bench experiments and data analyses
- Managing colleagues, working effectively in project teams and providing technical input to colleagues
- Can represent group in broad R&D teams; persuasive written and oral communications
- Proficient in the use of Microsoft Word, Excel and PowerPoint
- A Ph.D. in relevant biological science field with a minimum of 4-8 years of related experience.
New Haven, CT, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
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. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer