Senior Analyst II, Quality Control (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

Join bluebird bio’s enthusiastic and collaborative Quality Science and Technology (QSAT) team and in Quality Control as we continue on our mission of bringing out life-changing, novel gene therapies to patients! We are looking for an energetic and goal-oriented candidate to join our QSAT team, overseeing QC analytical methods for bluebird bio’s autologous cellular drug products in our late stage and commercial gene therapies. In your role, you will be responsible for managing and supporting all activities associated with analytical method lifecycle, such as method validation, method transfer, method investigation and remediation, and method implementation of in-process and release tests across the associated CxO network (Contract Testing Organizations and Contract Manufacturing Organizations.

HOW YOU’LL FLY

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

• Designing and overseeing QC laboratory studies performed for validation and/or remediation of QC methods used for inprocess, release, and stability testing of our autologous cellular drug products
• Authoring and review of method lifecycle documents such as protocols, reports, test methods, SOPs, and risk assessments required for the maintenance of the lifecycle for lot release and stability methods used by the QC unit.
• Analyzing data generated during method lifecycle activities using statistical software and/or Microsoft Excel.
• Owning and supporting cGMP routine testing by owning quality system records required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results.
• Participating in method monitoring of bioassay, molecular, and/or cell-based methods to support QC method lifecycle.
• Tracking project status and communicating to cross-functional teams including QC, CMC, and Quality.

WHAT YOU’LL BRING

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

• Bachelor’s or Master’s degree in Biology, Biochemistry, or related scientific discipline.
• A minimum of five (5) years of related experience in a QC GMP environment with late-stage clinical (Phase II, III) or commercial setting; commercial experience a plus.
• Experience with development, qualification, and validation of QC test methods (i.e. cell-based assay, flow cytometry, potency assay, and/or cell culture experience is desirable).
• Experience with owning quality system records required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results
• Good understanding of or proficiency with statistical software packages, such as JMP or Prism

Contract Length: 12 months

Location: U.S. Remote - East / Central Time.

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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