• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Scientist I

Job Number: 33881


Job Description

Our Client that is developing cutting-edge diagnostic testing for infectious diseases, is seeking a Scientist I to join their Assay Development team. This individual will work both independently and in collaboration with the team to provide technical support for commercialization and product development efforts.


  • Support the assay development efforts for the company’s commercialization, and FDA 510(k) submission, initiatives

  • Adhere to Good Laboratory Practice (GLP) guidelines in 21 CFR Part 58 (FDA, DHHS) relevant to Client’s laboratory activities.

  • Adhere to Client’s design control, Good Documentation Practice (GDP) and quality system procedures

  • Support stability protocols, plans and actions

  • Support development of BOM and assay design transfer activities

  • Work with general molecular biology laboratory equipment, biological specimens, reagents and chemicals

  • Maintain a safe, organized, and efficient work area following laboratory SOPs.

  • Design and execute experiments and test protocols according to study/test plans

  • Troubleshoot and investigate failures related to assay reagents and other consumables

  • Analyze experimental data and write study reports

Required Skills

  • Bachelor’s degree in Biomedical sciences, Medical Technology, or related technical field, or equivalent years of education and experience required

  • At least 1 year of experience in IVD assay development and commercialization required. Experience in molecular diagnostic assay development preferred.

  • Hands-on experience in DNA, RNA, PCR and general molecular biology laboratory techniques

  • Experience with working in BSL2 laboratory is preferred

  • Basic knowledge in statistical methods is preferred

  • Ability to write scientific and/or technical documents, such as experiment plans, protocols and reports

  • Ability to properly operate laboratory tools and equipment including pipettes, centrifuges, vortex mixers, incubators, PCR enclosures, biosafety cabinet, refrigerators and freezers

  • Ability to perform repetitive testing with a high level of attention to detail

  • General computer experience and ability to use corporate data/document/project systems and operate/monitor test equipment.

  • Applicable knowledge of Microsoft Office (including Excel).

  • Effective verbal and written communication with team members, scientists, engineers, and project managers.


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