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Principal Scientist, Gene Therapy GMP Interface, Assay Transfer Team - United States  

Company managed [?] Still accepting applications

Posted on : 24 June 2017

Project Description

Job Description 
  • We are building a world class gene therapy capability and are looking for an exceptional candidate to be responsible for coordinating all gene therapy analytical activities involving external partners operating under GMP. 
  • The successful candidate will be responsible for leading the Assay Transfer team, coordinating assay transfer, validation and testing activities in external labs.
  • The scope will include raw materials, cell banking, viral banking, drug substance and drug product release and stability testing.  
  • Responsibilities will include proposing and justifying specifications and authoring Specification Justification reports. 
  • The position will require close collaboration with internal and external Quality Control, Quality Assurance, and Process Development Technical Transfer team.


Qualifications
  • Experience in the areas of GMP assay validation and GMP testing in a pharmaceutical environment, preferably for gene therapy products. 
  • Practical knowledge and application of GMP regulations. Ability to manage all aspects of assay transfer, validation and testing in accordance with current guidelines and in compliance with regulations (e.g., FDA, EMA).
  • Demonstrated project leadership skills and ability to develop effective working relationships with internal/external sites and cross-functional project teams. 
  • Experience negotiating with and managing outsourced services.
  • Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively 


Education 
  • The ideal candidate will have a PhD in Analytical Sciences, Biochemistry, Biological Sciences or related discipline with at least 8 years of development experience in biotechnology industry, or M.S. degree with at least 12 years of development work experience. 

About Us 
  •  Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. 
  • Our company  is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).  
  • Our company  also manufactures and commercializes biosimilars of advanced biologics.   
  • Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.  
  • Our company  was founded in 1978 and today serves patients in nearly 70 countries.  
 
 
Our Science 
  •  We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.  
  • To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.  
  • For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. 
  •  Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease. 
  • We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS. 
  • As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.  
  • Our company  is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes. 
  •  This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.  
 
 
Our Corporate Citizenship 
  •  The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. 
  •  As a company, we are focused on improving science education and limiting the impact of our company on the environment. 
                                  
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