Scientist I

Job Title: Scientist I

Job Number: 33881

Location: , 

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.