Reporting to the Senior Director of Engineering, the Director of Process Development has the primary responsibility for providing leadership, technical expertise and vision to the “operationalization” of robust diagnostic testing workflows from proof of concept studies and early development activities to implementation, scale up and optimization in our state of the art Clinical Laboratory. These efforts shall include transfer of in-house developed diagnostic tests into production within Operations, and ongoing improvements of existing commercial tests. This individual shall provide leadership to a team of automation engineers and scientists whose tasks include the development of end-to-end laboratory workflows involving chemistry, liquid handling robotics / scripting, analytical instrumentation, informatics, and the required testing of these for new products and/or new technologies. The successful candidate will implement new best-in-class practices on generating requirements for these workflows, design the workflow through the creation of process maps and other tools, and integrate the workflow with the appropriate software, such as our Laboratory Information Management System (LIMS) and other existing upstream and downstream processes. He or she will use experimental design, six sigma and other evaluation techniques to measure and optimize key performance indicators, and propose and prioritize improvements to the workflow as needed. The leader will also work effectively in a cross functional environment, serving as a subject matter expert, to ensure that the developed workflows will meet corporate goals and regulatory requirements.
The Director will bring a passion for developing talent and teams. He or she will manage the Process Development team, including the recruitment of new members as necessary, the assignment of their responsibilities, the development of their skills, and the evaluation of their performance. The team-oriented leader shall collaborate with various internal stakeholders and external vendors to ensure the process development team operates with maximum effectivity in their roles.
- Manage internal resources and external partners to develop robust commercial lab workflows.
- Participate in or lead cross-functional teams in planning, developing, validating, and implementing robust and scalable integration solutions for a laboratory developed test product or platform for multiple products.
- Manage the generation of process documentation, including (as required) operational requirements, process descriptions, technical specifications, process models, and others.
- Generate and/or review process risk assessments and/or process FMEAs and develop risk mitigation plans
- Manage the generation of engineering and user test cases to support equipment the implementation of the workflow
- Provide process engineering support to clinical lab operations, product development and the rest of the company
- Define and manage the execution of scale-up capacity projects to ensure testing capability meets market demand.
- Provide technical leadership for timely resolution of complex process issues.
- Manage documentation to ensure regulatory compliance
- Collaborate with other functions, such as non-clinical biostatistics, on designing studies to evaluate method characterization, operational hold times, specification setting and others.
- Work with Project Management to build development schedules and track progress using a robust development process
- Participate in engagements with outside partners as necessary to incorporate their laboratory tests into Genomic Health business workflows
- Advice and present options, tradeoffs, recommendations, and plans to senior management on projects and associated product issues and risks.
- Serve as a subject matter expert on implementing diagnostic testing workflows within Genomic Health, proving expertise in this area to colleagues outside of Engineering
- Apply Robust Design / Design for Six Sigma principles to the development of solutions for Genomic Health workflows
- An engineering or science degree and at least 15 years of relevant process development experience with complex workflows and products.
- Experience in molecular biology, and the underlying chemistry of nucleic acid- based assays involving PCR, DNA sequencing, and related methods
- Expertise in the design, development, and validation of robust, scalable laboratory processes comprised of integrated automated and manual workflows, utilizing liquid handling robotics, analytical instrumentation, complex reagent sets, and software
- Superb written and oral communication skills, and demonstrated excellence in communicating and collaborating with colleagues and customers from a wide variety of scientific, engineering, operational, and regulatory disciplines across the organization at many different levels
- Demonstrated ability to effectively lead and participate in cross-functional project teams
- Critical thinking skills required to judiciously plan and prioritize project activities for maximum leverage and impact
- Demonstrated leadership skills required to align colleagues and stakeholders around a vision and a plan to achieve it, and to execute this plan
- Strong and consistent commitment to quality in the development, testing, and implementation of systems to be used in Genomic Health's laboratory developed tests.
- Ability to integrate and apply feedback in a professional manner
- Experience in the development of laboratory diagnostic tests using automated liquid handlers, qRT-PCR or sequencing.
- Experience in developing diagnostic test in a highly regulated environment (CLIA, FDA, etc.)
- Experience in project management
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Some travel (up to 10%) may be required