Principal Scientist - Process Development
T2 Biosystems, Inc. is an exciting early stage company whose mission is to revolutionize diagnostic medicine by providing innovative, accurate, easy to use and rapid diagnostic products that utilize T2MR technology to improve patients’ clinical outcomes and reduce healthcare costs. We are seeking a talented and highly motivated individual to join our Diagnostic Research and Development team.
You may be the person we’re looking for if you have:
· 10/8/6+ years of experience in the medical in vitro diagnostics assay industry.
· BS/M.S./Ph.D. in Molecular Biology,Chemistry, Biochemistry, or Chemical Engineering.
· Demonstrated leadership capability.
Your technical skills and abilities will include the following:
· Experience in materials and reagents development for IVD Molecular Diagnostic assays. Familiarity/expertise with oligonucleotideprimers and probes, enzymes, buffers, dNTPs, hybridization buffers, external controls, inhibition controls and probe-conjugated magnetic particles.
· Experience with reagent formulation, scale-up, process optimization, process control, reproducibility and stability and the ability to develop clear work instructions and test plans. Experience with oligo-magnetic particle conjugation and surface chemistry desired.
· Demonstrated ability to successfully transfer reagent processes to internal and/or external Manufacturing organizations for FDA-approved assays.
· Demonstrable experience with PCR nuclei acid amplification technologies, IVDs, Design Control, Quality System Regulations, cGMP including test method development and qualification.
· Hands-on experience in bench chemistry
Your responsibilities will include:
· Partnering with in-house stakeholders to ensure successful development and launch of IVD Molecular Diagnostic assays on the T2Dx automated platform.
· Working closely with the Assay Development teams in materials selection and reagent formulations meeting performance, reproducibility, stability and cost requirements.
· Serving as the lead process scientist/engineer to drive the development, optimization and scale-up of reagent processes; completing formulation and process guardband studies;and establishing allowable process tolerances.
· Developing and validating analytical and functional QC methods, establishing material/process acceptance criteria, including DOE and implementing inspection methods in R&D and Manufacturing
· Working closely with the Manufacturing team to develop final documentation; to successfully transfer material control/inspection methods and reagent processes; to manufacture reagent lots supporting FDA submission; and to complete reagent verification and validation.
· Establishing and completing requisitestability studies for FDAsubmission.
· Mentoring and direct supervision of technician and scientist level employees, including direct hands-on participation in chemistry, processing and inspection method development.
In addition, you will have:
· A high level of commitment and a track record of high quality work, with attention to detail.
· Demonstrable resourcefulness along with good analytical thinking, clear data analysis, and the ability to draw sound conclusions.
· The ability to work well with teams in a fast-paced, dynamic environment with an eye always on the goal.
The successful candidate will be highly motivated, results driven, exceptionally talented, analytical, and a team player. Please send your résumé and cover letter to careers@t2biosystems.com, and please identify the job title in the subject line.
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.