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Senior Research Associate

CorDx

San Diego, california


Job Details

Full-time


Full Job Description

About Us

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious diseases such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Responsibilities

Plan, perform, and record full laboratory processes for in-vitro diagnostic research and development that include but are not limited to the following responsibilities:

  • Assay development, validation, and sample analysis under RUO/GLP/cGMP conditions.
  • Write SOPs, validation protocols, and reports.
  • Work with management and QA to maintain and improve quality systems
  • Provide high-quality documentation of all lab-related activities, including, for example, assay batch record, sample inventory, etc.
  • Perform a QC function to review data and reports to ensure the accuracy of all laboratory-related processes.
  • Maintain regular communication with the study director and other project staff and become a point of contact to the client.
  • Plans and conducts moderate to complex assessments, evaluations, and studies
  • Perform analytical studies such as LOD, Cross-Reactivity, etc.
  • Adhere to safety protocols, and BSL-2 requirements.
  • Maintains accurate and complete R&D records and laboratory notebooks, MSR logs and files

Requirements

  • A minimum of a Bachelor's in a scientific field with 5+ years or an advanced degree (MS/Ph.D.) with at least 3 years of relevant experience.
  • Able to follow instruction with desire and willingness to work effectively independently and/or in cross-functional teams where tact and collaborative efforts prevail
  • Strong planning and organizational skills; ability to critically review and summarize data a must
  • Effective communication skills (written and verbal) – technical writing a plus
  • Working knowledge of Quality Systems Regulations (QSR), Good Manufacturing Practices (GMP) and ISO 13485 standards
  • Knowledge of the following scientific related principles, theories and application of equipment
  • SDS-PAGE, Western Blot, Antibody Conjugation, ELISA, Quantstudio 5, Kingfisher extraction.
  • Experience in the In Vitro Diagnostic or medical device manufacturing industry preferred
  • Proficient in computer software programs such as MS Word, Excel, Prism.

Benefits

  • Health Care Plan (Medical, Dental, & Vision)
  • Retirement Plan
  • Paid Time Off
  • Training & Development

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