T2 Biosystems, founded in 2006 by renowned scientists from MIT and Mass General Hospital, is an in vitro diagnostic company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies. We are using our T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, and can detect cellular targets at limits of detection as low as one colony forming unit per milliliter, or CFU/ml. Our initial development efforts utilizing T2MR target sepsis and hemostasis, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. We have completed a pivotal clinical trial for our T2Dx diagnostic instrument, or T2Dx, and T2 Candida panel, or T2Candida, which have the ability to rapidly identify the five clinically relevant species of Candida, a fungal pathogen known to cause sepsis. Upon receiving regulatory clearance, we intend to commercialize T2Dx and T2 Candida and our goal is to launch these product candidates commercially in the United States in the first half of 2015.
On September 22, 2014, T2 Biosystems received market authorization from the U.S. Food and Drug Administration (FDA) for its first two products, the T2Candida® Panel and the T2Dx® Instrument for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. T2Candida and T2Dx, for the first time, provide sensitive detection of specific sepsis-causing pathogens directly from a whole blood specimen in approximately four hours. All other currently FDA-cleared detection systems require cultured blood samples for species-specific identification and take two to five days or more to provide results.
T2 Biosystems was named to the FierceMedicalDevices "Fierce 15" list in 2012, received the prestigious SBANE award in 2013 and received the Most Promising Company award at the Personalized Medicine World Conference in 2014.
We are seeking a talented and highly motivated individual to join our team as a Director of Assay Development (Molecular). This individual will lead a molecular diagnostics assay development project and will report to the Senior Director, Diagnostic Assay Development.
Responsibilities:
- Lead a molecular diagnostics assay development project and team in a hands-on manner through pre-development, development, verification, validation, FDA submission, and pre-launch activities
- Effectively plan, resource and achieve milestones and timelines
- Provide leadership in the assay development process to ensure project deliverables are achieved and results are high quality
- Provide technical leadership in assay and reagent QC methods and process development
- Coach and support team members to ensure best practice in the execution of product development projects
- Lead project-specific technical discussions with external parties as needed
- Develop and maintain effective working relationships with contract research and manufacturing organizations as needed
- Oversee remedial action and troubleshooting to support manufacturing, QC and technical support as needed
- As a member of the R&D management team, pro-actively improve efficiency, quality, and effectiveness of research and development efforts
- Achieve assay, reagent, and controls performance metrics while maintaining QSR compliance of project documentation and processes
Skills and Experience:
- Ph.D. or M.S. in a Physical or Life Sciences discipline
- Minimum of 8 years of relevant experience and IVD industry experience in assay development
- Demonstrated technical, managerial, and leadership expertise in assay development
- Experience with one or more of the following: QC test method development, reagent formulation development and optimization, materials and formulated reagent QC or process development for reagents and controls
- Development experience in FDA-approved products
- A strong work ethic and ability to generate high quality work under tight deadlines
- Demonstrated management skills and self-motivation
- Ability to motivate and guide others to meet objectives
To apply, please follow the link to our careers page at:
http://www.t2biosystems.com/careers/
T2 Biosystems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, gender, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other protected class.