Scientist - Immunoassay and Enzymatic Assay Development

Job Summary 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 Scientist 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 and immunoassay analyzers; Post development activities include manufacturing support, technical support, and other post launch product activities including going to the customer sites for validation

DUTIES & RESPONSIBILITIES:

• Participate in the development of operating procedures, regulatory requirements, safety guidelines; writing technical reports and SOPs, 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; Prepares reports as requested
• Applies technical knowledge to analyze, investigate and resolve assigned scientific problems.
• Performs functional testing and troubleshooting of equipment and investigates assigned area(s) by utilizing standard scientific principles.
• Obtains and analyzes test data.
• Develops appropriate documentation of findings and implemented solutions and communicates results to project scientific staff
• May be required to make brief technical presentations
• May provide direction or supervision to research associates.
• May perform elementary computational modeling of scientific phenomena.
• 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. Additional Functions 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 Masters degree in a scientific or related discipline and a minimum of two or more years of scientific experience with a Bachelors degree. Equivalent scientific experience may be substituted in lieu of education.
• An understanding of scientific concepts, principles; and theory of biochemistry/immunology/enzymology
• Experience in immunoassay development, especially assays using chemiluminescent immunoassay techniques including antibody labeling and antibody conjugations to magnetic particles.
• Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables.
• Good communication, computer, documentation, presentation, and interpersonal skills, and ability to work both independently and as part of a team.

Salary:$73,700 - $128,780