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.

Under direct supervision, this position assists in the general operations necessary for the production of recombinant proteins for use in clinical diagnostic products. Maintains a variety of confidential and sensitive electronic and hard copy records and statistics. Follows standard operating procedures, regulatory requirements, safety guidelines, and good manufacturing practices and prepares reports as requested. Assists in maintaining a clean room environment and recognizes and reports any abnormal events or circumstances.

DUTIES & RESPONSIBILITIES:

• Assists in the preparation of culture media and buffer solutions for the production of recombinant proteins.
• Assists in cell harvesting, cell lysing, fermentation, buffer preparation, and purification.
• Cleans, prepares, and autoclaves glassware and components.
• Cleans, sterilizes, batches, and monitors tanks and fermenters, and operates and cleans filtration equipment.
• May assist with batch process testing to assure specifications are met.
• May assist in completing various good manufacturing practices, safety, and regulatory required forms.
• Assists in shipping, packaging, and record keeping.
• Maintains the 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.

Job Qualifications

• Typically requires an associate's degree in a related discipline. Equivalent professional experience in an academic or industrial biology or microbiology laboratory may be substituted in lieu of education.
• Must demonstrate an understanding of basic biological/microbiological theories and principles as well as an awareness of laboratory protocols, and regulatory and safety requirements.
• The ability to interpret data and identify issues
• Good interpersonal, verbal and written communication skills to explain general information and effectively communicate with all levels of employees
• The ability to maintain the confidentiality of sensitive information
• The ability to use basic office/scientific software and knowledge of basic computer operations and applications.
• Ability to work both independently and in a team environment is essential as is the ability to work extended hours as required.

Job Category

BioTech

Experience Level

Entry-Level (0-2 years)

Workstyle

Onsite

Full-Time/Part-Time

Full-Time Hourly

Pay Range Low

35,390

Pay Range High

52,625

Travel Percentage Required

None

Relocation Assistance Provided?

No

US Citizenship Required?

No

Clearance Required?

No