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Scientist (R&D)

Location: La Mesa
Posted on: November 18, 2021

Job Description:

Diazyme, an affiliate of General Atomics, is a cGMP and ISO 13485 certified medical device manufacturer. Diazyme uses its proprietary enzyme technologies to develop diagnostic reagents which can be used on most automated chemistry analyzers in user-friendly formats. Their products include test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, and electrolytes.

The candidate will join Diazyme 's R&D team to develop immunoassays and enzymatic assays used in clinical settings. The ideal candidate will be responsible for participant in the assay development, assay optimization, and application on various clinical chemistry analyzers; Post development activities include manufacturing support, technical support, and other post launch product activities including going to the customer sites for validation.

DUTIES AND RESPONSIBILITIES: Participate in the development of operating procedures, regulatory requirements, safety guidelines; writing technical reports and SOP's, responsible for assay performance data collection, assay validation and documentations needed for FDA submissions; manufacturing practices and prepares reports as requested.
Maintains and updates a variety of confidential and sensitive electronic and/or hard copy records and/or files.
Supports operation of scientific systems by evaluating and interpreting needs and problems and develops effective approaches to resolving those issues.
Troubleshoots, analyzes, and repairs systems in assigned area by utilizing standard scientific principles.
Provides documentation and makes technical presentations as required, and may assist in responding to proposals for new or the expansion of existing business opportunities.
Directs the activities of technicians and may direct the activities of less experienced professional staff.
May represent the organization in providing solutions to technical issues associated with specific projects.
Responsible for observing all laws, regulations, and other applicable obligations wherever and whenever business is conducted on behalf of the Company.
Expected to work in a safe manner in accordance with established operating procedures and practices.
Performs other duties as assigned or required.

We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.
Job Qualifications: Typically requires a Bachelor or Master 's degree in a scientific or related discipline and a minimum of two or more years of scientific experience with a Bachelor 's degree. Equivalent scientific experience may be substituted in lieu of education.
Additional desired qualifications - a Ph.D. or three or more years of scientific experience with a Bachelor 's degree and two or more years of experience with a Master 's degree.
Must demonstrate a good understanding of scientific concepts, principles, and theory and the ability to follow and apply basic scientific knowledge, adapt standard techniques, and utilize the required diagnostics, tools and equipment, while ensuring safety and regulatory compliance.
Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment.
Good communication, computer, and interpersonal skills are required, enabling an effective interface with other professionals, the production of appropriate documentation, and the presentation of results to a limited internal audience.

Keywords: GENERAL ATOMICS, La Mesa , Scientist (R&D), Other , La Mesa, California

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