Job Description
Diazyme Laboratories, Inc. (www.diazyme.com), is a cGMP and ISO 13485 certified medical device manufacturer. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic reagents which can be used on most automated chemistry analyzers in user-friendly formats. Products include test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, sepsis and electrolytes.
Under general supervision, this position is responsible for the operations necessary to support development activities for clinical diagnostic products. The individual works with an interdisciplinary team, maintains project notes and Design History Files, and presents updates to the Research and Development team and management. Additionally, the role involves participating in the development of standard operating procedures for the project and conducting laboratory experiments in a safe and regulated manner.
DUTIES AND RESPONSIBILITIES:
- Participates in an interdisciplinary team performing life sciences research and development experiments in the laboratory.
- Prepares buffers, stock solutions and operates laboratory equipment needed for research and development.
- Analyzes experimental data and participates in design of experiments to be performed in the laboratory
- Maintains and updates a variety of confidential and sensitive electronic and/or hard copy project records and/or files.
- Presents findings during research and development meetings.
- Completes and submits various good manufacturing practices (GMP), safety, and regulatory related documents as required.
- Assists with scale manufacturing of developed products with testing to assure that product specifications are met.
- Maintains strict confidentiality of sensitive information.
- Other duties as assigned or required.
- 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.
We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.