Sanofi Group Principal Research Associate in Framingham, Massachusetts
Principal Research Associate
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Genzyme Corporation (a Sanofi company)and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union
status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Principal ResearchAssociate: POS 00472104-1
Sanofi Genzyme focuses on developing specialty treatments fordebilitating diseases that are often difficult to diagnose and treat, providinghope to patients and their families.We accomplish our goals throughworld-class research, collaboration with the global patient community, and withthe compassion and commitment of our employees. With a focus on rare diseasesand neurodegenerative diseases, we are dedicated to making a positive impact onthe lives of the patients and families we serve. Genzyme's portfolio oftransformative therapies, which are marketed in countries around the world,represent ground breaking and life-saving advances in medicine. As a Sanoficompany, Genzyme benefits from the reach and resources of one of the world'slargest pharmaceutical companies, with a shared commitment to improving thelives of patients.
The Biomarkersand Clinical Bioanalyses departmentsupports pre-clinical and clinical programsby developingvalidated assays and performing sample testing forpatient immune surveillance and pharmacokineticand biomarker analyses. The group is seeking a candidate with hands on experiencein developing and validating ligand binding, PK, enzymatic activity, andcell-based assays in a GCLP environment while adhering to regulatory agencyexpectations.
Developing, validating,and implementing complex biomarker and bioanalytical assays under the confinesof challenging timelines with minimal supervision
Providing support (clinical testing, long-term maintenance) for currentclinical assays
Keeping abreast of relevant scientific literature and regulatory guidances
Working closely with otherteam members as part of a coordinated effort to meet the business needs
Authoring SOPs,technical reports, abstracts, and publications and presenting scientific datato fellow colleagues
Thesuccessful candidate will be able to work independently to design assays,execute on experimental plans, and analyze and interpret the resulting data.
Master’s degree in thefield of biochemistry, immunology, biology, or other life-science field and 5or more years of relevant industry experience. In exceptional cases a Bachelor’s degree in the field of biochemistry,immunology, biology with 8 or more years of demonstrated expertise in therelevant field may be considered.
A diverse skillset in bioanalytical/biomarkerassay development methodologies such as ligand binding (ELISA, MSD, etc.),Western Blotting, multiplexed biomarker analysis, flow cytometry, enzymatic, andcell-based assays
Familiaritywith basic statistical and data analysis software such as EXCEL, SoftMax Pro, JMP,GraphPad Prism, FlowJo, etc.
Familiar with regulatoryexpectations (FDA and EMA) and industry’s best practices in analytical assay developmentand validation for PK, immunogenicity (anti-drug antibody), and biomarkers
Outstandingwritten and oralcommunication skills along with ability to work collaboratively in a teamsetting
Immunology background,preclinical and/or clinical flow cytometry expertise
Experience working in aGxP environment and clinical study support
Job: Laboratory/Process/Device Development
Primary Location: United States-Massachusetts-Framingham
Job Posting: Mar 6, 2016, 11:00:00 PM
Job Type: Regular
Employee Status: Regular