On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business (“Oncology Newco”) as a new entity, with the completed transition expected by the end of 2021.

 

ABOUT THE NEST

At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.

ABOUT THE FLOCK

We seek an experienced leader to manage our Quality Control Oncology methods group. This position will oversee QC analytical method lifecycle and validations for our late stage /commercial oncology gene therapy products as well as new clinical methods. The main objective of this role is to maintain validated state of late stage analytical methods for our lentiviral vector for Abecma while helping to implement phase appropriate methods for our earlier clinical lentiviral vector and autologous cell drug products. The role will report to the Senior Director of QC Oncology and will work closely with our corporate partners, internal and external labs, analytical product leads, and analytical development. "• Lead the QC Oncology Methods group responsible for lifecycle management of QC methods for in process, release and stability as methods are improved, replaced, and/or introduced.

HOW YOU’LL FLY

As a Quality Control, you'll help to bring more patients their bluebird days by:

  • Lead the QC Oncology Methods group responsible for lifecycle management of QC methods for in process, release and stability as methods are improved, replaced, and/or introduced.
  • Determine method validation requirements, author and/or approve method transfer and validation plans, protocols and reports
  • Build relationships with GMP test labs (both internal and external) and external partners or collaborators
  • Contribute to and/or approve regulatory CTD sections for method descriptions and method validations (BLA and IND level)
  • Work with “client groups” within QC (internal and external contract test labs, stability and specifications, and analytical product leads) to deliver results and continuously improve QC processes and methods for the oncology business.
  • Manage method trending for commercial methods
  • Partner with labs for maintaining and qualifying reference standards/critical reagents
  • Interface with the oncology-focused CMC teams, Quality Assurance, Regulatory Science, Manufacturing, Process Development/MSAT, and bluebird partners.
  • Manage and develop a team of 10-15 scientists and 2-3 direct reports at the manager level

  • MS or PhD in a Chemistry, Biochemistry, or other related field
  • 15+ years in biopharmaceutical method validation and/or QC
  • Experience with both FDA and EMA commercial filings and regulatory analytical expectations
  • QC method experience in biologic, gene therapy and/or autologous cell products, techniques include cell-based potency methods, flow cytometry, DNA extraction, qPCR, ELISA, and other modern wet chemistry technologies.
  • Highly developed communication skills and emotional intelligence to build relationships within bluebird, corporate partners, and with regulatory agencies
  • Demonstrate a strong initiative and scientific leadership
  • Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
  • Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

WHAT YOU’LL BRING

You’re the bird we’re looking for if you:

  • MS or PhD in a Chemistry, Biochemistry, or other related field
  • 15+ years in biopharmaceutical method validation and/or QC
  • Experience with both FDA and EMA commercial filings and regulatory analytical expectations
  • QC method experience in biologic, gene therapy and/or autologous cell products, techniques include cell-based potency methods, flow cytometry, DNA extraction, qPCR, ELISA, and other modern wet chemistry technologies.
  • Highly developed communication skills and emotional intelligence to build relationships within bluebird, corporate partners, and with regulatory agencies
  • Demonstrate a strong initiative and scientific leadership
  • Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
  • Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

All our birds embrace the principles of the bluebird bio culture:  b colorful, b cooperative, b yourself.

bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.  Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.

bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

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