Quality Control Scientist Sr Cerezyme Assay Remediation

Job Description
Description
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.

Responsibilities:

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.

Qualifications
Basic Qualifications

? Bachelor's degree and 12+ years of experience.

? Master's degree and 9+ years of experience.

? PhD and 6+ years of experience.

Preferred Qualifications:

? Expert technical expertise in specified platform.

? Excellent computer skills in relevant applications.

? Strong written and verbal communication skills.

? GMP experience

Preferred Qualifications

Excellent organizational skills.

People and Project management skills.

Thorough understanding of relevant statistical methods.

Company

Genzyme

Job Code

State or Province

Massachusetts

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