Senior Scientist, IVD Assay Development

Kelly Science & Clinical is seeking a Senior Scientist, IVD Assay Development for a one-year contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.
Workplace: Onsite in Sunnyvale, CA.
Position Title: Senior Scientist, IVD Assay Development
Position Type: One-year contract
Pay rate: $55-65 per hour.
Company: Kelly Science & Clinical
Overview and Responsibilities
The Senior Scientist I is responsible for the design and development of real time PCR and RT-PCR IVD assays in an FDA-QSR and ISO13485 compliant organization. This position is part of Assay R&D and will be located onsite in Sunnyvale, CA.

• Evaluate, test, and optimize real time PCR and RT-PCR assay procedures and assay prototypes based on design of experiments and design input requirements.
  
• Apply analytical problem-solving skills and strategies for the development of complex in vitro diagnostic real time PCR and RT-PCR tests for infectious diseases. Perform rigorous analytical studies required to demonstrate technical feasibility of complex assays.
  
• Design, set up and execute complex experiments including data collection, summary, and critical analysis to meet project, department, and company objectives.
  
• Independently devise strategies and experimental plans for development of new sample prep, library prep, and sequencing methods
  
• Perform hands-on evaluation, testing, development, and troubleshooting of new sample prep, library prep, and sequencing methods
  
• Work in a BSL2 environment and handle a variety of clinical sample matrices and microorganisms.

Qualifications

• Bachelors degree in related field (e.g. Molecular Biology, Biochemistry, Bioengineering, Chemistry, Biology and Genetics) with 5+ years of relevant industrial experience OR Masters degree in related field with 3+ years of related work experience OR Doctoral degree in related field with 2+ years of related work experience.
  
• Must have a strong background designing, developing, and optimizing real time PCR and RT-PCR assay.
  
• Following product development lifecycle process and design control
  
• Executing studies to verify sensitivity and specificity of oligonucleotide designs in PCR detection and melt
  
• Evaluating and testing reagent formulations, lyophilization, and stabilities
  
• Integrating PCR detection with sample preparation and device fluidics for assay prototype feasibility studies
  
• Maintaining detailed experimental records and documents results in a technical report in a laboratory notebook
  
• Analyzing data using statistical tools such as Microsoft Excel or Minitab
  
• Presenting data at internal technical meetings.

Preferred:

• Experience in implementing and following robust design control processes for CE and/or US-IVD tests.
  
• Designing oligos for microorganism detection with experience/knowledge of melt probes designs.
  
• Short-read (e.g. Illumina) and long-read (e.g. Oxford Nanopore) sequencing experiments and subsequent data analysis
  
• Familiarity with data analysis in a Linux/Unix environment

Why Join Us:

• Competitive compensation package and potential for permanent placement following the temporary period.
  
• Opportunity to work at the forefront of biotechnology innovation in a collaborative and dynamic environment.
  
• Access to ongoing career development and networking opportunities through Kelly Science & Clinicals expansive network of industry experts and recruiters.

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isnt the perfect match, your profile will remain within our network, ensuring youre connected to a wealth of future opportunities in the field of science and clinical research.
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