Clinical Testing Vendor Support Specialist

Location
Cambridge, MA, United States
Posted
Aug 25, 2018
Ref
1041757
Hotbed
Genetown
Required Education
Bachelors Degree
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? Do you love computers, numbers and people? The Preclinical Translational Bioassay Development group at bluebird bio is seeking a Clinical Testing Vendor Support Specialist with the ability to balance a variety of technical responsibilities and priorities according to bluebird bio's growing need for translational assay support across our portfolio of cell and gene therapies.

The primary function of this Clinical Testing Vendor Support Specialist role will be to manage translational and correlative data across all therapeutic programs at bluebird bio. The successful candidate will work with testing facilities to manage assay transfers, bioassay data transfers, assay monitoring/performance and reporting. The successful candidate will harmonize testing timelines with Clinical Operations, Data Management and Bioinformatics teams in support of bluebird's clinical and pre clinical programs. The candidate will be responsible for reviewing data to ensure quality and consistency of test results and initiate investigations into identified assay issues. The candidate will have the opportunity to become part of an innovative, collaborative and energetic team that will develop analysis and visualization tools applicable to all bluebird bio programs.

Key Responsibilities
  • Manage preliminary clinical data transfers for all assay results generated at Contract Testing Organizations (CTOs), ensuring all data transfers are placed into associated databases appropriately and on schedule.
  • In support of preclinical and clinical studies, review and analyze preliminary assay data for assurance of assay quality, consistency, and adherence to established testing protocols. Identify and report potential data issues to the head of Translational Bioassays.
  • Manage relationships with CTOs and help manage oversight of existing assays, as well as the transfer and qualification or validation of new assays.
  • Interface closely with other functions including Clinical Operations, Data Management, and Preclinical Development.
  • 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), BS with 5+ years of relevant experience or MSc with 2+ years of relevant experience within the biopharmaceutical industry.
  • Knowledge of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP)
  • Strong experience in assay development and vendor management is required.
  • Prior experience with data manipulation, analysis, interpretation and database management is required, e.g. Spotfire, Excel, Prism and SQL (Structured Query Language) experience is preferred.
  • Experience in qualification and validation of bioassays, e.g. biomarkers, PD, PK, BD, ADA and laboratory developed tests (LDT).
  • Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
  • Excellent communications skills and ability to influence across multiple functions
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourselfIndependently motivated, detail oriented and good problem solving ability
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment