Senior Manager, Quality Control

Company: bluebird bio
Location: Cambridge
Posted on: February 25, 2021

Job Description:

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 Join bluebird bio's enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approach. This is an exciting hands-on leadership role within our Quality Control stability team at Senior Manager level. We seek an experienced Quality Control professional to lead activities associated with QC strategic management of stability programs for ancillary materials, starting materials and drug products in support of our early and late-phase clinical development to ensure successful clinical and commercial regulatory filings in the EU and US. You will provide significant contribution to the daily operations of the Quality Control laboratories as well as strategies for future growth and improvements. This position requires partnering with various internal laboratory operations as well as a Contract Testing Organizations (CTO) network. The position requires a strong knowledge of cGMP/ICH/FDA/EU regulations.
HOW YOU'LL FLY

• Lead a team to manage a multi-product portfolio in a stability program for ancillary materials, starting materials and drug products in support of our early, late-phase clinical, and future commercial development
• Review and approve ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for ancillary materials, starting materials and clinical drug product
• Utilize statistical software to trend stability data and establish retest and expiration dates
• Oversee cross-functional laboratory investigations related to stability and laboratory operations
• Collaborate with Quality management and CTOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports
• Prepare, review and/or approve CMC stability sections for clinical regulatory filings, MAA, and BLA
• Manage timelines to meet department and corporate goals WHAT YOU'LL BRING You're the bird we're looking for if you:
  • Bachelor's or Master's degree in a scientific discipline, 10-15 years of related experience in QC GMP environment, and at least 5 years managing direct reports
  • Strong knowledge of cGMP/ICH/FDA/EU stability regulations
  • Solid understanding of statistical analysis as it relates to product stability trending and establishment of shelf life
  • Experience and strong understanding of statistical software packages such as JMP
  • Superb communications-both written and oral skills and "do-what-it-takes" attitude
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Excellent organizational skills, ability to navigate and be successful in fast-paced and highly-matrixed work environment with changing priorities
  • Experience with CTO/CMO management and strong interpersonal skills with the ability to motivate others, influence, and negotiate challenging situations
  • Be ready to embrace 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. Will you now or in the future require bluebird bio to commence ("sponsor") an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)? --*
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Keywords: bluebird bio, Cambridge , Senior Manager, Quality Control, Executive , Cambridge, Massachusetts