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Manufacturing & QC Associate I

CareDxBrisbane, Australia | California, United StatesOnsite

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.
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:


  • 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.

Qualifications:


  • 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.While performing the duties of this job, the employee is regularly required to use hands and fingers, handle or feel, and talk or hear. The employee frequently is required to sit, stand and walk. There will be periods of time during the workday where you will be sitting for 3-4 hours in a row.

Require regular use of hands to operate office equipment and type on the keyboard. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Additional Details:


Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.Our competitive Total Rewards package includes:

  • Competitive base salary and incentive compensation
  • Health and welfare benefits including a gym reimbursement program
  • 401(k) savings plan match
  • Employee Stock Purchase Plan
  • Pre-tax commuter benefits
  • And more!

In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.


By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice


and consent to receive email communication from CareDx.


******** We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.#LI-Onsite

Life at CareDx

CareDx: Transforming Transplant Patient Care Through Novel Surveillance Management Solutions CareDx, Inc. is dedicated to improving the lives of organ transplant patients through non-invasive diagnostics. By combining the latest advances in genomics and bioinformatics technology, with a commitment to generating high quality clinical evidence through trials and registries, CareDx is at the forefront of organ transplant surveillance and pre-transplant HLA typing solutions. NASDAQ:CDNA About AlloSure® AlloSure is the first and only non-invasive blood test that directly measures allograft injury and identifies the probability of active rejection to better manage kidney transplant patients. AlloSure is a clinical-grade, proprietary Next-Generation Sequencing (NGS) based test to detect donor-derived cell-free DNA (dd-cfDNA) in order to identify organ injury in kidney transplant recipients. AlloSure is analytically validated as a sensitive, specific, and precise measurement of dd-cfDNA. AlloSure detects active rejection (acute active ABMR, chronic active ABMR, or TCMR) with high accuracy, outperforms serum creatinine in kidney transplant recipients, and is highly sensitive in distinguishing ABMR from no ABMR. AlloSure is performed in the CareDx CLIA-certified laboratory. http://www.allosure.com/ About AlloMap® AlloMap Molecular Expression Testing is a non-invasive blood test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing in conjunction with standard clinical assessment. AlloMap testing measures the expression levels of 20 genes from a blood sample. The combined expression of these genes is represented as an AlloMap test score. AlloMap is performed in the CareDx CLIA-certified laboratory and has been commercially available in the United States since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked for the European Union in 2011. Use of AlloMap is also included in the International Society for Heart and Lung Transplantation (ISHLT) Practice Guidelines, published in August 2010, the worldwide standard for the care of heart transplant patients. http://www.allomap.com/
Thrive Here & What We Value1. Focus on improving the lives of organ transplant patients worldwide2. Taking great care of our people, so they take even greater care of our patients3. CareDx offers products, testing services, and digital healthcare solutions along the pre and post-transplant patient journey4. CareDx is the leading provider of genomics-based information for transplant patients5. Competitive Total Rewards package including: Competitive base salary and incentive compensation, Health and welfayer benefits, 401(k) savings plan match, Employee Stock Purchase Plan, Pretax commuter benefits
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