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Job Title: Translational Research Scientist
Duration: 12 months
Location: Kenilworth, NJ
Qualifications:
BS, MS or PhD in a life sciences discipline (Biochemistry etc.) or Chemistry
Required Experience and Skills:
3 years of pharmaceutical industry experience (PhD), 5-6 years (MS), or 7-8 years (BS)
5 years of direct experience in immunoassay development
Strong interpersonal, verbal and written communication skills
Ability to work independently; strong leadership skills
Ability to execute within a matrixed organization
Preferred Experience and Skills:
Broad knowledge of drug development process and translational medicine
Hand-on experience in clinical development/operation or managing the implementation of biomarker assays in support of drug development
Experience with Regulated Clinical bio-analysis
Software skills:
MS office suite(Excel, word, outlook, power-point)
Note: Onsite lab based role. The key words are: immunoassay or immunochemistry assay (must have), clinical biomarker or biomarker (nice to have).
Must haves:
Cell Culture,
Cell sorting,
Flow cytometry,
Invivo experiments,
Immunoassays,
Biomarker assays.
Responsibilities:
Develop and validate immunoassays within TMB for all therapeutic areas and all phases of clinical development.
Assist in lab instrument validation.
Assist in the transition of biomarker assays from Basic Research to Clinical by providing technical guidance on fit-for-purpose assay validation.
Interface with biomarker leads and operation leads in early and late stage clinical development to execute on biomarker strategies in clinical trials.
Writing memos, assay validation reports, clinical sample analysis reports and publications summarizing data, and writing/updating lab SOPs.
Serve as a subject matter expert in immunoassay development and validation, collaborating with project teams, biomarkers leaders, clinical operation and regulatory affairs on the implementation of these assays in clinical trials.
Ubertal Inc
