Quality Control Management, Gene Therapy

bluebird bio

Quality Control

November 26, 2014

Quality Control Management, Gene Therapy

Experienced QC professional to join our growing quality team

 

bluebird bio is developing potentially transformative, one-time gene therapies for severe genetic and orphan diseases. At the heart of bluebird bio’s product creation efforts is its broadly applicable gene therapy platform for the development of new treatments for diseases with few or no clinical options. bluebird bio has two clinical stage product candidates in development, one for childhood cerebral adrenoleukodystrophy (CCALD) and one for beta-thalassemia major/sickle cell disease, and an early stage oncology program in partnership with Celgene Corporation.

 

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.    We seek an experienced Quality Control professional to manage all activities associated with QC release testing for Drug Product disposition.  You will provide the organization with management of QC testing for clinical trial material through commercialization.  The position requires experience with technology transfer, CMO/CTO management and a strong knowledge of cGMP/ICH/FDA/EU regulations. This is an exciting hands-on leadership role within our quality team.  

 

About the position:

  • Work as part of a cross-functional team to lead QC activities for technology transfer of manufacturing and testing processes to external CMO/CTO’s.
  • Manage release testing for Drug Product disposition.
  • Management of data review, analysis, identification of trends, and complex problem solving.
  • Management of assay troubleshooting and identifying and implementing improvements to existing assays.
  • Write and review QC SOPs and qualification/validation protocols and reports.
  • Prepare, execute, and review deviations, change controls, CAPAs, OOT/OOS.
  • Prepare and review CMC sections of regulatory filings.
  • Managing timelines to meet corporate goals.
  • This position requires some travel domestically and internationally.

 

About you: 

  • Bachelor’s degree in a scientific discipline, 8-10 years of related experience in QC GMP environment. 2+ years in management role.
  • Strong knowledge of cGMP/ICH/FDA/EU regulations.
  • Experience with technology transfer and CTO/CMO management.
  • Strong technical knowledge and skill base. Experience with cell culture, flow cytometry, and qPCR preferred. General knowledge of manufacturing for gene therapy preferred.
  • Leadership skills and demonstrated ability to work in a productive and collaborative cross-functional manner.
  • Superb communications—both written and oral skills and “do-what-it-takes” attitude.
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
  • Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself.

This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular.  bluebird bio is a publicly traded company on the NASDAQ  Global Select Market and trades under the symbol BLUE.  We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.

To be considered for this exciting career opportunity, please apply through our website. www.bluebirdbio.com

bluebird bio, 150 Second Street, Cambridge, MA 02141 

bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.

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