Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com
The mission of Corporate Quality Operations- Quality Control Technical Services is to develop, qualify, validate, transfer and support analytical methods; to prepare, qualify and provide critical reagents/specialty columns; to troubleshoot reagent and assay performance for Genzyme QC laboratories globally; and to support regulatory submissions and post-approval commitments. For this position, the scientist will manage and direct a team of analysts and scientists involved with validating, transferring and performing receptor binding (Biacore), cIEF, ELISA, HPLC and bioassay assays for protein products and reagent (primarily antibodies) characterization.
· Develop and author complex, explicit documentation for new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics.
· Design and execute analytical method development, and qualification and validation.
· Solve assay/analytically-related process problems.
· Identify potential problems and proactively suggest technical solutions based upon analytical expertise and knowledge of product/process.
· Major contributor to the understanding and interpretation of results and how they impact the design of subsequent experiments.
· Help determine technical objectives and approaches to assignment.
· Guide the successful completion of major projects and function in a project leadership role.
· Develop project strategy in consultation.
· Work independently.
· Represent the organization in providing solutions to difficult technical issues associated with specific projects.
· Independently employ in-depth technical knowledge to define and manage laboratory studies on investigations of quality control procedures.
· Manage and direct the work of analysts and scientists.
· Interact with external personnel on significant technical matters often requiring coordination between organizations.
? Bachelor's degree and 12+ years of experience.
? Master's degree and 9+ years of experience.
? PhD and 6+ years of experience.
? Expert technical expertise in specified platform.
? Excellent computer skills in relevant applications.
? Strong written and verbal communication skills.
? GMP experience
§ Excellent organizational skills.
§ People and Project management skills.
§ Thorough understanding of relevant statistical methods.
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