Scientist,Translational Bioassays Laboratory Head

Location
Cambridge, MA, United States
Posted
Sep 22, 2018
Ref
967213
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Preclinical Development group works with bluebird bio's discovery platforms and translational research teams to generate the hypotheses, mechanism-of-action, and efficacy data that fuel the bluebird pipeline. We also work with our clinical and regulatory teams to generate the toxicology and biodistribution data that is critical to translating each of bluebird's innovative therapies safely from research into patients. In doing so, we continuously strive towards our mission to be the biotech world's best preclinical development organization for immunotherapy and gene therapy. Our valued associates experience room to grow their careers, a supportive, flexible and collaborative work environment, and respect for a diversity of experiences and perspectives.

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 group at bluebird bio 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.

The successful candidate will have the opportunity to become part of an innovative, collaborative and energetic team that will develop assay analysis and visualization tools applicable to all bluebird bio programs.

Key Responsibilities
  • 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.


Requirements
  • 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.