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
Do you have excellent attention to detail? Are you an ardent learner who is always looking to expand your knowledge? Are you self-motivated and have the right ‘get-it-done’ attitude?
The Translational Bioassay Development flock is seeking a Laboratory Head with the ability to balance a variety of technical responsibilities and priorities according to bluebird bio’s growing need for preclinical and exploratory clinical assay support across our portfolio of cell and gene therapies. The primary function of this role will be to manage a laboratory conducting preclinical and exploratory clinical translational assays across all therapeutic programs at bluebird bio. The successful candidate will work with several groups to implement the most appropriate assays towards the success of existing and new gene therapy programs, to support IND enabling studies, and transfer assays supporting early phase clinical studies. The successful candidate will drive the design, development, execution and analysis of assays in early clinical studies, such as enzyme assays, CFC, anti-drug antibody assessments, PCR, flow cytometry, HPLC, cytokine/chemokine determinations, and other biomarkers of pharmacokinetic, pharmacodynamic and clinical responses.
HOW YOU’LL FLY
As a Senior Manager/Associate Director lab lead, reporting to the Head of Translational Bioassays, you'll help to bring more patients their bluebird days by:
- Manage the qualification/validation and implementation of key assays to support IND-enabling studies in support of preclinical development.
- Manage the transfer, validation/qualification and implementation of exploratory assays to support early phase clinical studies.
- Review and analyze assay data for assurance of assay quality and consistency.
- Interface closely with other functions including Immunotherapy, Translational Oncology, and Preclinical Research.
- Work with head of Translational Bioassays to prepare data presentations and relevant updates to cross-functional teams.
- Possess excellent organizational skills, with the ability to multi-task in an extremely fast-paced environment.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Strong scientific background in a relevant field (Biology, Biochemistry, Immunology, other), PhD with 4+ years of relevant experience or MSc with 8+ years of relevant experience within the biopharmaceutical industry.
- Strong experience with assay development, particularly experience in qualification and validation of bioassays, e.g. biomarkers, flow cytometry, cell-based methods, molecular methods, PD, PK, , ADA and laboratory developed tests (LDT).
- Significant experience and working knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
- Experience managing direct reports and outside vendors as well as the ability to work successfully in a team-oriented environment.
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.