• , US

Company:  Confidential

Job Title: Scientist I

Job Number: 76836

Location: , US

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.

Responsibilities

* 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.

Application Deadline: 2024-05-13

 

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