Personalis is a rapidly growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient’s cancer and immune response. Our ImmunoID NeXT Platform® is enabling the development of next generation immuno-oncology therapeutics and diagnostics.
The Senior Scientist, Reagents Development within the Product/Process Development Group will lead the development of Reagent Qualification Methods, Quality Control (QC) Protocols and SOPs, Strategy for Production Reagents’ Supply, Testing and Optimization and related Troubleshooting and Analysis in support of existing or new IVD product development efforts in a regulated environment (FDA-QSR, CLIA, CAP, ISO regulations). An ideal candidate would have in-depth knowledge on DNA/RNA extraction, library preparation, target enrichment, and development of customized reagents for IVD product development in a regulated (FDA/ISO) environment.
- Lead development of reagents for NGS-based IVD and LDT products. Develop QC method for reagents, set QC specifications and collaborate cross-functionally to facilitate the effective transfer of methods and processes to the operation team.
- Lead documentation in compliance with regulatory and quality practices (FDA-QSR, CLIA/CAP, ISO regulations).
- Building rapport with end-users, process owners, and coordinating with cross-functional projects teams, lead and/or conduct studies required for the implementation of new or revised QC Testing methodologies.
- Collaboratively author and revise QC testing methods, SOPs and reports for new and existing reagents to ensure the successful implementation in Production.
- Develop formulation and kitting strategies to optimize samples-processing capacity. Lead troubleshooting efforts, analyze data and help drive key decisions.
- Supervise one or two Junior/Senior Research Associates.
- Work with the Regulatory and Quality Assurance teams to ensure that documentation meets QSR standards and support Supply Chain with Material Management and documentation needs.
- Interface with reagent supply vendors.
- Be highly committed and deliver results in a fast-paced environment.
- PhD Scientist with a minimum of 3 years of experience or Masters’ degree with more than 5 years of experience in molecular biology, Genetics and related fields, with emphasis on Reagents QC Development and Optimization for diagnostic assays in FDA-QSR, CAP/CLIA, GMP regulated laboratory environments.
- Core competency in Reagents QC assays development, Testing and Analysis.
- Skilled at writing clear SOPs and validation reports, and experience with quality management, including design control, risk analysis, and mitigation strategies.
- Hands-on scientist, experienced with adapting and validating assays for automated processes and continuous workflows. Proven success working individually and within a team.
- Deep understanding of essential molecular biology methods such as PCR, nucleic acids purification and quantitation is required. Next generation sequencing, functional and analytical methods development, DOE, Data analysis and Troubleshooting.
- Work effectively with laboratory personnel to implement the reagents strategy and methods.
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package.