Senior Scientist, IVD Assay Development

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Base pay range

55.00 / hr - $65.00 / hr

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Senior Recruiter | PhD-level Scientist | Working Parent | Immigrant | Helping scientists answer the question of what's next?

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.

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

Bachelor's degree in related field (e.g. Molecular Biology, Biochemistry, Bioengineering, Chemistry, Biology and Genetics) with 5+ years of relevant industrial experience OR Master's 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 & Clinical's 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 isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.

Seniority level

Seniority level

Associate

Employment type

Employment type

Contract

Job function

Job function

Science, Analyst, and Research

Industries

Biotechnology Research and Medical Equipment Manufacturing

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