BioAnalytical Lab Operations Manager
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
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
The Clinical Lab Operations flock is all about bridging the gap between our lab vendors and the Clinical team across the bbb portfolio. Whether it’s making sure data cut deadlines are met, lab processes are as smooth as possible, or finding creative solutions to meet protocol testing requirements, we are driven by our patients and our “can do” attitudes. Come work with an agile, analytic group of birds that loves rising to the challenge much as we do swapping quarantine hobbies!
HOW YOU’LL FLY
• Planning and overseeing all operational activities required to manage the life cycle of clinical samples (collection, sample tracking, processing, analysis, data delivery and cleaning process, and final sample disposition)
• Managing Central and Bioanalytical lab vendor selection and conducting on site operational and technical visits
• Writing and overseeing all Central and Bioanalytical lab related study documentation such as lab manual, vendor oversight plan, and site facing documentation
• Managing lab kit set up, central lab specifications, lab manuals, and study lab budgets
• Managing end-to-end sample tracking and logistics for clinical samples, including query/discrepancy resolution, by working closely with the CTM, central laboratories, and specialty lab vendors
• Working with Data and Stats Managers to develop data transfer agreement for lab data
• Proactively supporting the Clinical Development Operations team during data cleaning to ensure oversight of clinical samples, data transfer and reconciliation procedures
• Identifying, handling and communicating all vendor related investigations, deviations and CAPAs and working with Compliance and QA to resolve
• Overseeing clinical lab invoices and lab budget, contract, and assay updates related to protocol schedule of events changes
WHAT YOU’LL BRING
• Bachelor’s degree with Science focus
• Experience managing clinical labs study startup and oversight
• 7+ years experience in clinical lab operations, and 3+ years of experience in a clinical study laboratory oversight role preferred
• Strong verbal and written communication skills
• Excellent interpersonal and organizational skills
• Ability to deal with competing priorities
• Strong reasoning, detail orientation and problem solving abilities are essential
• Ability to work on teams and on multiple concurrent projects, and works well under general direction with tight timelines
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.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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