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SAS Development Testing FDA Consultant
(Jobs in Guilford, CT)
 
Requirement id 107762
Job title Consultant
Job location in Guilford, CT
Skills required SAS, Written And Verbal Communication Skills, Development, Testing FDA
Open Date 25-Jun-2020
Close Date
Job type Contract to Hire
Duration 5 Months
Compensation DOE
Status requirement not found
Job interview type ---
   Email Recruiter: coolsoft
Job Description Consultant: SAS, Written And Verbal Communication Skills, Development, Testing FDA

Candidate must be our W2 Employee.

We should submit only GC,GC - EAD, L2-EAD,H4-EAD and Citizens.

Job Description :

A vibrant biotech company invested in making products that make a difference in health care, is in search of passionate Product Development Scientist, who can thrive in a fast-paced innovative environment. The individuals must be highly independent and hands on in the laboratory.

Responsibilities:

Experience with: reagent development and formulation best practices in biological and diagnostic workflows

Lateral Flow Assays or Personal diagnostic workflows development

Familiarity with the process of obtaining FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics

Conduct and analyze evaluations for multi-step, multi-component biological workflows.

Prepare and deliver analyzed reports to the team lead.

Conduct and analyze routine baseline operations for multi-step, multi-component biological workflows.

Prepare and deliver relevant analyses (timeline, component performance, etc.), suggesting root cause activities and corrective actions to team lead.

Participate in development of appropriate test regimes and analyses to evaluate procedural modifications and improvements.

Familiarity with statistical analyses using software such as SAS, JMP, R or Minitab beneficial

Qualifications:

Minimum of 3 years of industry experience with a Bachelors degree in Engineering, Biology, Biochemistry, Molecular Biology, or Biological Engineering. Minimum of 1 year with a M.S. Alternatively, 4 years of directly related experience in lieu of degree may be considered as well.

Working experience with all aspects of biological assay development on path to commercialization.

Excellent organization, writing and communication skills are required, and the ability to interact well in group meetings/working environments.

Laser-like attention to detail, ability to follow complex protocols accurately and reproducibly.

Self-starter with a ferocious work ethic who can work independently, but who also functions well in a collaborative team environment.

Familiarity with statistical testing processes, including trend analysis, accelerated aging techniques, and study design.

Keen powers of observation, able to identify and capture critical insights associated with testing processes.

Takes ownership of tasks and problems and provides solutions.

Demonstrated soft skills: able to maintain excellent rapport with colleagues in the face of tight timelines and potentially contentious results.
 
Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 107762 while calling.
 
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(Consultant: SAS, Written And Verbal Communication Skills, Development, Testing FDA in Guilford, CT)
     
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