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Scientist I/II/ or Senior, Lateral Flow Assay Development

Company: Gateway Recruiting, INC.
Location: San Diego
Posted on: September 24, 2022

Job Description:

JOB DESCRIPTION:The scope of this position is responsible for the expansion of lateral flow assay development for drugs of abuse and on market support.RESPONSIBILITIES:

Executes and conducts research; may develop or recommend new procedures related to R&D processes.Uses advanced professional concepts to contribute to the development of company concepts and principles and to achieve objectives in creative and effective ways.Investigates, creates, and develops new methods and technologies for project advancement with limited assistance.Exercises good judgment on details of work when less common or proposed methods or procedures are necessary. - Is expected to detect problems in using standardization procedures because of the condition of the sample, difficulties with the equipment, etc.Works on moderate to more complicated or compound problems in which analysis of situations or data requires evaluation of identifiable factors from multiple disciplines; Proposes more throughout potential solutions to advanced problems based on experience.Conducts experiments on more complex problems, and seeks advice from more experienced colleagues for more complex/advanced scientific challenges.Determine methods and procedures for new assignments and provides guidance to junior personnel.May plan and work on projects of moderate complexity under limited to no supervisionMay direct less experienced RAs in their day-to-day work and assist in problem-solving.May have supervisor duties for small teams may direct less experienced RAs in their day-to-day work and assist in problem-solving. May be involved in interviewing, training employees; planning, assigning, and directing work, and resolving technical problemsProvides sound and original suggestions for new problems.Perform analytical test methods on the finished products based on CLSI and other FDA guidelinesParticipate as an integral member of the scientific staff in research strategy and methodology to resolve issuesProvide recommendations and observations to scientific staff and management on results of projects/tasks. - Play a key role in the research strategies and tactics for new or existing R&D projects.May conduct interviewing, training employees, planning, assigning, directing work, and resolving technical problems.Maintain records of laboratory activities and notebooks in a professional, accurate manner. - May provide support to regulatory and intellectual property activities.Transfer developed processes to the Manufacturing Team. Write and revise process document reports and transfer protocols.Ability to create, review, and work with SOPs, MPs, and Batch RecordsOperate complex laboratory equipment and perform routine maintenance and repair. - Interface with contracted repair technicians as required. Understand the theoretical basis for analytical instrumentation.Functionally direct junior research staff, as required.Initiate literature review and searches to support ongoing research activities. Summarize findings in final form to management and recommend follow-up actions.Generate oral and written reports and to summarize laboratory activities and projects per the R&D managers request. - Initiate communication with R&D manager and functions as necessary to coordinate other staffs activities effectively.Monitor and maintain necessary laboratory supplies, with approval by senior department staff or the R&D managerWrite verification and validation protocols and reports with minimum or no guidance. order materials needed to complete procedures as needed.Work involving urine, blood, or other potentially infectious materials may be requiredKnowledgeable of federal and other regulations, e.g., QSRs, ISO, ISO 13485, CMDRUnderstands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities.

Keywords: Gateway Recruiting, INC., San Diego , Scientist I/II/ or Senior, Lateral Flow Assay Development, Other , San Diego, California

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