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
Come join bluebird bio's enthusiastic and collaborative Quality Science and Technology (QSAT) team in Quality Control as we continue on our mission of bringing our life-changing, novel gene therapies to patients! As a Senior Analyst II, you will manage and/or support analytical method lifecycle management activities for bluebird bio's cellular drug products in our late stage and commercial gene therapies. You will be responsible for managing and supporting all activities associated with method lifecycle, such as method validation, method transfer, method 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:
- Manage Quality Control related communications within CTOs and CMOs
- Design and oversee external QC laboratory studies performed for validation and/or remediation of QC methods used for in-process, release, and stability testing
- Author and/or review of method lifecycle documents such as protocols, reports, Test Methods, SOPs
- Own quality systems required for change controls, deviations, laboratory investigations, CAPAs and out-of-specification (OOS) related to method implementation or method performance
- Own and/or support cGMP routine testing by owning quality systems required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results
- Manage activities required for method transfer and validation including coordination of sample shipment, submitting legal contracts, and owning POs
- Ensure all documentation complies with cGMP regulations and industry guidelines.
WHAT YOU'LL BRING
You're the bird we're looking for if you have:
- BS or MS in a scientific discipline, 3-5+ years of related experience in QC GMP environment in a clinical and/or commercial environment
- Experience in cell-based bioassays (such as potency assays), molecular biology (such as qPCR), ELISA, and/or biochemistry
- Strong track record of interpreting cGMP/ICH/FDA/EU regulations
- Experience with and good understanding of statistical software packages such as JMP
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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