Associate Director/Director, External Lentiviral Vector (LVV) Manufacturing

Cambridge, MA

Gene therapy for severe genetic and orphan diseases

 

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 clinically meaningful options. bluebird bio has three clinical stage product candidates in development, one for childhood cerebral adrenoleukodystrophy (CCALD), one for beta-thalassemia major and another for sickle cell disease. bluebird bio is also engaged in an early-stage oncology program.

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approaches. bluebird bio seeks an entrepreneurial manufacturing professional to help drive the strategy for our early and late-stage clinical development programs.  This role encompasses leading our external lentiviral vector manufacturing operations team and is ideally suited for a professional with strong management experience leading and evolving this function to support a broad portfolio of therapies. We are interested in candidates with a proven track-record of successfully integrating activities and perspectives across functions to achieve our goal to deliver therapies that transform the lives of patients.

 

Key Responsibilities:

  • Apply manufacturing concepts, tools and practices while driving to re-define how they are applied in this novel and growing field.
  • Hire, develop and mentor a high-performance team with a vision of setting industry-leading scientific standards in this nascent field.
  • Build processes and relationships with external and internal development and manufacturing organizations.
  • Identify risks and drive continuous improvement in the development and manufacturing process through technological innovation and alignment with regulatory and commercial manufacturing requirements.
  • Drive functional compliance to regulatory requirements, and quality systems in a GMP environment.
  • Author, review, and approve CMC documentation for regulatory filings as well as attending pertinent regulatory meetings as the functional owner.
  • Work in partnership with Quality, Process Development, Supply Chain and Manufacturing Sciences & Technology functions to ensure group activities are aligned with corporate objectives
  • Lead improvements of manufacturing process operation to ensure scalable solutions for clinical and commercial manufacturing of lentiviral vector
  • Work collaboratively with key departments to trend and analyze manufacturing data
  • Travel 20-30%

Qualifications:

  • A B.S. in the pertinent life sciences or engineering, with 10+ year’s relevant industry experience. Advanced degrees desirable.
  • Experience managing a broad organization as well as external manufacturing providers, partners, and or academic collaborations is required.
  • Prior experience in the management of GMP vector or cell processing functions in the cell or gene therapy field is a plus.
  • Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
  • Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
  • Independently motivated, detail oriented and good problem-solving ability
  • Excellent communication and organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
  • Process characterization and validation experience is a plus.
  • A passion for addressing the critical unmet medical needs of patients
  • Willingness to embrace and demonstrate 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 were named to the 2012 FierceBiotech Fierce 15. 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 bonus, stock options, commuter/parking benefits, etc.

 

Share this job

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.