Sr. Research Associate/Scientist (IVD Development)
Predicine, Inc., United States
Job Description
Predicine is a Silicon Valley-based global precision medicine company that is committed to developing the first- and best-in-class liquid biopsy cancer diagnostics and precision medicine portfolio to address the unmet medical needs in global drug development. We aim to provide innovative blood- and urine-based molecular diagnostic tests to enable precision medicine. Predicine’s liquid biopsy platform and molecular insight solutions enable biopharma companies to accelerate drug development and expand discovery in oncology. We partner with the top 10 leading global biopharma companies to support biomarker-driven clinical trials in US, EU, APAC including China. At Predicine, we believe people are our most important asset and we are dedicated to creating a great place to work. We value a culture of creativity, integrity, responsibility, productivity, and teamwork.
We invite people who share the same values to join us!
What you’ll get to do
In this role, you will be responsible for conducting the assay validation work for both oncology and infectious disease branches in the development of Predicine products. The role is intended to be an operational lead for performing validation studies under the design control environment. In this role, there are three strategic areas of focus: understanding the validation design to conduct the experiment, proactively sample preparation for the validation process and collaborating with multiple departments to ensure the smooth validation progress and troubleshooting the process and understanding the validation data. All these efforts will support the commercial launch of liquid biopsy oncology products and infectious disease products.
You will work cross-functionally with team members from across the organization to ensure that Predicine is providing robust products. You must be able to operate in a fast-paced organization and have extremely high standards and accountability on quality of deliverables. This is an exciting opportunity to join a fast high growth company to accelerate your growth, contribute, and make an immediate impact on cancer care worldwide.
Requirements
- Conduct assay validations based on the predefined validation plans to meet the design control requirements.
- Drive the validation process, understand the validation data and troubleshoot issues arisen during validation process.
- Summarize the validation data and update to the management team.
- Coordinate with operation or automation groups to execute the verification and validation studies needed to support the product development.
- Communicate effectively within the group and with other cross-functional groups.
Who you are
- Master or PhD degree in molecular biology, or closely related field. Minimum of 3 years of lab-related experience with the Master’s degree.
- Previous lab experience in molecular biology or assay validation preferred.
- Be willing to work in the lab and learn FDA and other regulatory authorities’ guidelines on general principles related to validations.
- Proven proficient in reading and communication skills.
- Good team player and willing to work cross-functionally with multiple groups including working with lab operations, quality, regulatory and marketing teams.
https://apply.workable.com/predicine-inc/j/35EF637...
Benefits
Competitive Benefits Package