Scientist I
Company: INVIVOSCRIBE INC
Location: San Diego
Posted on: January 15, 2021
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Job Description:
Scientist IAs a Scientist I at Invivoscribe you are responsible
for developing new and improving existing products in a regulated
research environment. It is his/her job to ensure that the research
and development activities follow company protocols and comply with
applicable regulations, industry standards and company Standard
Operating Procedures (SOPs). More specifically:* Supports
development projects, which can include generating analytical data
for an FDA submission.* Maintains a laboratory notebook that
records all aspects of experimental design and results. Reviews
laboratory notebooks of lower level direct reports if applicable.
When applicable, maintains electronic copies of experiments,
procedures, instructions, data and analysis in appropriate
locations.* Initiates, designs and executes product development
studies including product planning, feasibility, optimization,
validation and verification with minimum supervision.* Writes and
finalizes development plans (Product specifications, Design and
Development Plans), protocols and reports according to known
standards when they are available. Responsible for accuracy and
completeness of auditable documents.* Solves complex development
challenges independently. Works closely with cross-functional
departments to develop, transfer and sustain new products.Skills
and Experience Required:* Ph.D with 3+ years of industry
experience, an MS with 5+ years or a BS with 10+ years in Molecular
Biology or scientifically related field in a regulated
environment.* Familiarity with quality and regulatory requirements
for medical devices including QSR, ISO quality system standards and
the IVD Directive.* Extensive knowledge of molecular biology,
molecular immunology, biochemistry, chemistry or related
disciplines.* Hands-on experience with next-generation sequencing
for diagnostics or cancer research, nucleic acid purification from
clinical samples, multiplex PCR and assay optimizations using
DOE.
Keywords: INVIVOSCRIBE INC, San Diego , Scientist I, Other , San Diego, California
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