QC Analyst II, Stability (Contract)

Location

Somerville, MA | United States

Job description

ABOUT THE NEST

The nest is a place where every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new gig, you become part of a flock that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:

• Persist for Purpose
• Be Compassionate
• Stay humble and curious
• Keep it real
• Celebrate (sm)all wins

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

ABOUT THE FLOCK

Our Quality Control team is looking for an analyst to perform activities associated with QC stability programs for ancillary materials, starting materials, and/or drug products in support of our early and late-phase clinical and commercial 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. This position requires partnering with various internal laboratory operations as well as a Contract Testing Organizations (CTO) network. 

HOW YOU’LL FLY

You'll help to bring more patients their bluebird days by: 

• Contributing to the operation of stability programs across a multi-product portfolio.
• Originating ICH compliant stability plans, protocols, and reports; coordinate, review, trend, and report stability test data for ancillary materials, starting materials, and clinical drug product.
• Contributing to the management of stability sample inventory, performance of stability sample pulls, and sample submissions to test laboratories.
• Managing and documenting stability test schedules and tracking of pending data for the purpose of maintaining performance of program metrics.
• Collecting raw data from test labs, perform cGMP data review, collate and archive.
• Utilizing statistical software to trend analytical data associated with stability testing.
• Collaborating with Quality, internal functional areas, and CTOs, to review and perform documentation of deviations, CAPAs and OOS/OOT investigation reports.
• Contributing to preparation of CMC stability section for regulatory filings by providing necessary data and verification.

WHAT YOU’LL BRING

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

• Bachelor’s degree in a scientific discipline, 3+ years of related experience in QC GMP environment.
• Strong knowledge of cGMP/ICH/FDA/EU stability regulations.
• Good understanding of statistical analysis as it relates to product stability trending and establishment of shelf life.
• Experience with and good understanding of statistical software packages such as JMP.
• Superb communications—both written and oral skills – and strong interpersonal skills; experience with CTO/CMO interaction a plus.

Contract Length: 6 months

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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