Scientist I

Company: INVIVOSCRIBE INC
Location: San Diego
Posted on: January 15, 2021

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