Senior Associate Scientist II, Purification Process Development

Cambridge, MA

Join bluebird bio’s enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approaches.  bluebird bio seeks an outstanding purification process development associate scientist II to continue building our lentiviral vector manufacturing platform.  The candidate will have the opportunity participate in development, scale-up, and manufacturing.   We seek candidates with proven ability to successfully work independently and collaboratively across functions to meet aggressive project timelines, with the ultimate goal to deliver therapies that transform the lives of patients.

 

Primary responsibilities:

 

  • Planning and execution of viral vector purification development activities encompassing early and late stage development.
  • Screening, optimization, and scale-up of chromatography (e.g. affinity, IEx, HIC, SEC) and filtration processes including microfiltration, depth filtration, ultrafiltration, diafiltration, and sterile filtration.
  • Assist in technology transfer to GMP manufacturing by generating development reports and providing on-site technical support.
  • Support scale down model development and process characterization activities.
  • Authoring and assistance in the technical review of supporting documents, reports, including CMC sections for regulatory filings.
  • This is a hands-on position requiring conducting laboratory experiments, good documentation review skills, good writing skills, and the flexibility to move between the management and execution of each required function as needed.

 

Requirements: 

 

  • BS with 8+ years of directly related experience or MS with 6+ years of directly related experience.  Degree emphasis in Chemical Engineering, Biochemistry, Bioengineering, Molecular Biology, or related field preferred.
  • Ability to conduct laboratory experiments while complying to safe work environment and good laboratory notebook practices.
  • An in-depth understanding of the fundamentals of purification of biologics or more specifically viral vectors; such as column chromatography, normal and tangential flow filtration.
  • Good scientific aptitude allowing formulation of hypothesis, design and execution of experiments, data analysis and sound scientific conclusions.
  • Proficient with ÄKTA systems and UNICORN control software.
  • Experience with high-throughput process development techniques and statistical design of experiment (DoE).
  • Knowledge of GMP/ICH/FDA regulations preferred.
  • Understanding of analytical methods used to support biologics purification process development is preferred.
  • Ability to work in a collaborative team environment and to adapt to changing priorities.
  • Superb organizational and communications—both written and oral skills—and a “do-what-it-takes” attitude.
  • Experience in working with and managing outside vendors.
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