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 Associate Director within the Process Development Group will align with the goals of the company and provide the framework for growth, by developing and implementing systems and processes to address any gaps; receive assignments in the form of high level objectives and determine the optimal use of resources to meet schedules and goals. He/she will provide leadership and guidance to direct reports within the latitude of established company policies. As the Associate Director, he/she will lead the development, optimization, automation and validation of new or existing NGS-based testing products in an FDA regulated production facility
- Work on issues of diverse scope where analysis of situation/ data requires evaluation of a variety of factors, including an understanding of current business trends. Follow processes and operational policies in selecting methods and techniques for obtaining solutions.
- Act as an advisor to subordinate(s) to meet schedules and/or resolve technical problems. Develop and administer schedules, performance requirements.
- Lead feasibility, development & validation, and process improvement studies. Manage the transfer of NGS based technology, workflows or tests from research to production and interface with Research, Bioinformatics, and other technical product teams and functional groups to ensure the smooth qualification and introduction of new or revised products.
- Build rapport with end-users, lab supervisors and process owners. Additional responsibilities include user training, optimizing the workflows, and on-going support for the end-users. Lead troubleshooting efforts, analyze data and help drive key products related decisions.
- Collaboratively author and revise Verification and Validation protocols, SOPs and reports for new or existing products to ensure their successful implementation in Production.
- Manage a team of Scientists and Research Associates, assign tasks, supervise execution of experiments, review data and reports. Mentor direct reports to support their training/career growth and complete annual performance reviews. Represent the Development function at program and other core team meetings. Evaluate/communicate risk and manage expectations at the program level.
- PhD Scientist with >8 years of experience in molecular biology research and development, human genomic sequencing and related fields, with emphasis on Process Development and Optimization of diagnostic assays in a FDA regulated laboratory environment.
- Substantial experience in optimizing laboratory methods and workflows and scaling up molecular biology assays to enable high-throughput laboratory operations.
- Proven success in managing collaborative and individual projects.
- 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.
- Deep understanding of essential molecular biology methods such as PCR, nucleic acids extraction and purification, quantitation, and quality control is required. Next generation sequencing experience is preferred.
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package.