CareDx, Inc. (formerly XDx, Inc.), based in Brisbane, California, is a publicly traded molecular diagnostics company focused on the discovery, development and commercialization of high value, non-invasive tests to enhance the care and long-term outcomes of transplant recipients. The company has commercialized AlloMap Gene Expression Profile Testing, which aids physicians in surveillance of heart transplant recipients.  New data was recently presented at ISHLT 2014 that further supports the clinical utility of AlloMap. CareDx, Inc. also develops new tests for other solid organ transplantation, which are in development.

Title: Manufacturing Associate I

Manager: Manufacturing Manager

FLSA: Non-exempt 

Classification: Regular Full Time

Department: Manufacturing

Location: Brisbane, CA

Management: N/A

General Description  

The Manufacturing Associate I will participate in manufacturing and process development activities. Relies on established SOPs and QC Testing procedures to perform the functions of the job. Can work in the lab directly from an SOP with moderate training. Has knowledge of commonly-used concepts, practices, and procedures within molecular biology. Capable of setting up materials or equipment for experiments. Can collect data for routine experiments with limited guidance. Relies on work priority from supervisor as well as limited experience to plan and accomplish tasks or goals.  

Responsibilities are as follows, but not necessarily limited to:

• Participates in manufacturing of FDA-approved diagnostic products as well as development and verification activities. 

• Summarizes, tabulates and verifies experimental data; starts to analyze data with direct guidance.

• Completes cGMP batch records with minimal errors 

• Works to follow CareDx’s practices and procedures to support compliance requirements.   

• Operates well in a team-oriented, scientific environment. 

• Performs other related duties and assignments as required

• Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health & Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisors of all observed hazardous conditions or unsafe work practices.

● A BS degree in a related scientific discipline such as molecular biology or biochemistry and 1 to 2 years related experience in a research, clinical or industrial laboratory or equivalent combination of related education and experience.

● Enjoys hands on laboratory work

● Desirable experience would include high-throughput real time PCR, cGMP manufacturing, and molecular biology process development.  

● Manufacturing/Development of in-vitro diagnostics would be an asset.  

● Thrives in a highly collaborative, fast-paced, team-based environment.

Benefits & Perks:

We provide Medical, Dental, Vision and Life Insurance, Flexible Spending and Dependent Care Accounts, Commuter Accounts, 401(k), 3 weeks of vacation, 5 days sick leave, 1 personal floating holiday, 9 paid holidays, gym reimbursement, ping pong, foosball, BBQ’s, Yoga, social hours, and more!

Work Environment:

Travel is not a primary aspect of this position although travel may be requested from time to time. An employee in this position may work in an environment, or visits facilities, in which safety, environmental and health concerns may demand constant attention. Adherence to the Corporate and/or Plant policies, rules, and regulations in these areas is required.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

All your information will be kept confidential according to EEO guidelines.