Development Scientist - NGS Emphasis

Organization
Invivoscribe Technologies, Inc.
Job Location
San Diego, CA 92121
Job Description

Basic Function and Scope of the Position

DS is responsible for implementing company protocols in laboratory experiments. It is their job to ensure that product research and development is performed in a manner that complies with applicable regulations and industry standards.

Essential Functions

  • Supports development projects, which can include generating analytical data for an FDA submission.
  • Designs, leads execution of, and documents highly complex experiments that support the development of diagnostic reagents and assays. Experimental design will include all of the appropriate controls. Assists with writing study protocols and reports, which may be auditable.
  • Writes and finalizes protocols and reports according to standard guidelines when they are available. May publicly present study results. Responsible for accuracy and completeness of auditable documents.
  • Maintains a laboratory notebook that records all aspects of experimental design and results. Reviews laboratory notebooks of lower level direct reports. When applicable, maintains electronic copies of experiments, procedures, instructions, data, and analysis in appropriate locations.
  • Uses laboratory techniques such as preparation of buffers and media, aseptic technique, cell culture, specimen processing, nucleic acid isolation and manipulation, PCR, and gel and capillary electrophoresis.
  • Independently operates laboratory equipment such as thermocyclers, next generation sequencing platforms, spectrophotometers, fluorometers, centrifuges, cell counters, autoclaves, scales, and DNA isolation workstations.
  • Performs data analysis using available software such as Microsoft Excel, JMP, and GeneMapper.
  • Ensures that laboratory reagents are properly stocked, equipment is maintained, and that laboratory bench is clean and clutter-free.
  • May support project Core Team and Design Review activities.
Requirements
  • PhD or MS degree in molecular biology or related field with at least 2-year post graduate experience.
  • Priority will be given to the candidates that have: Experience with next generation sequencing technology and experience in product development. The ideal candidate will have experience in an FDA regulated environment.
  • Extensive knowledge of molecular biology, molecular immunology, biochemistry, chemistry or related disciplines.
  • Extensive experience with nucleic acid purification, amplification, and related techniques.
  • Ability to troubleshoot and solve complex technical issues across multiple assays and platforms.
  • Ability to analyze complex data and come to valid scientific conclusions.
  • Working knowledge of quality and regulatory requirements for medical devices including QSR and ISO quality system standards and the IVD Directive.
  • Demonstrates achievement orientation with performance measurements, improved outcomes, challenging goals, and innovations. Impacts and influences others by showing concern with professional reputation, using direct persuasion, facts, and figures, and giving presentations tailored to the audience.
  • Demonstrates conceptual thinking by recognizing key actions and underlying problems and making connections and seeing patterns. Demonstrates analytical thinking by anticipating obstacles, breaking problems apart systematically, making logical conclusions and seeing consequences and implications. Demonstrates initiative by persisting in problem-solving and addressing problems before asked.
  • Ability to follow and adhere to Standardized Operating Procedures (SOPs) as well as written and verbal instructions.
  • Able to exercise independent judgment in solving complex technical problems.
  • Ability to work independently as well as in a team environment. Ability to plan short-and long-term (3-6 months) activities and coordinate their implementation.
  • Ability to manage multiple complex projects and changing priorities, consistently meet critical deadlines and train employees.
  • Well-developed technical writing skills and verbal communication, able to create and deliver presentations before groups of professionals.
  • Proficient computer skills and good working knowledge of Microsoft Office programs (Word, Excel).
  • Willingness to learn and take on new challenges.
  • Highly motivated, self-driven, and focused on the project goals.

Physical Requirements and Work Environment

  • Ability to perform some tasks that can be monotonous and physically demanding in a lab environment.
  • Most activities will take place at a desk and on a computer.
  • Occasional safe lifting of up to 30 pounds.
How to Apply
  • Be sure to reference Job Code: JXDS in the subject line of either your email or cover letter to be considered for this position.
  • No phone calls or walk-ins inquiring about this position.
About Our Organization

Invivoscribe is dedicated to improving the quality of healthcare worldwide by providing high quality, reliable, cutting-edge tools for molecular biology, molecular diagnostics, and personalized molecular medicine™.
Products manufactured in our GMP facility include a comprehensive selection of PCR-based reagents and controls for gene rearrangement, chromosome translocation, and gene mutation testing. Customers include pharmaceutical and biotechnology companies; cancer research, academic and hospital testing centers, and reference laboratories. Our CE-marked IVD products, which are available for sale and use only outside the US, target biomarkers that have demonstrated clinical utility. Our tests are used to identify, stratify and monitor hematologic cancers. Our companion diagnostic products assist in the development of pharmaceutical agents and devices. Many of our gene rearrangement and gene mutation testing products are covered by exclusive-licensed patents.

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