Technical Leader - Assay Development

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The Position

We advance science so that we all have more time with the people we love.

Roche is the world’s #1 provider of companion diagnostics, offering unrivaled experience in developing and commercializing predictive tests that enable personalized treatment strategies for patients.

The Technical Leader, Assay Development (Technical Leader) will have expertise in consumable metrology, reagent analytical chemistry, system integration, genomics, sequencing, infectious disease, biochemistry assays, development of ambient stable formulations including lyophilization, and molecular biology, including principles of nucleic acid hybridization, probe and primer design, nucleic acid extraction, laboratory automation, as well as a background in the integration of molecular biology methods with complex consumable devices for in vitro diagnostics. In addition, the Technical Leader will have a demonstrated understanding of the Diagnostic Design Control Process with prior experience designing and developing nucleic acid-based “sample to answer” molecular diagnostic products within a regulated environment.

The Technical Leader will lead a team of scientists, engineers and research associates in research and development activities. This person will provide cross-functional team leadership to ensure achievement of project milestones according to timeline, budget and specifications. The Technical Leader will build and provide leadership for an effective team in a high growth environment including hiring, on-boarding, developing, goal setting, performance improvement and disciplinary actions; creating a positive environment and instilling a sense of urgency and strong can-do attitude in the team.

• You will direct and manage multiple ePlex product and process characterization initiatives; you will provide cross-functional team leadership to ensure achievement of project milestones according to timeline, budget and specifications.

• You will work closely with manufacturing to complete key product and process characterization activities to ensure a robust production process that meets performance expectations.

• You have experience in the development of stability protocols, QC protocols, design for manufacturability, use of DOE, critical parameter management, and optimization of critical to quality attributes

• You will cooperate with Regulatory and Quality departments for successful compliance with regulatory guidelines and design control processes.

• You will partner with finance, marketing, IP, legal and product care leadership functions to ensure all stakeholder inputs are considered; providing clear communication in tradeoff decisions between cross functional stakeholders; you will provide regular updates to executive leaders

• You will manage staff; provide staff with coaching, training and opportunities to develop skills, and give ongoing, constructive and timely feedback on performance and progress toward goals and expectations

• You will set challenging team goals and ensure scientific and statistical best practices are used to attain these goals.

• You will drive team debate/discussions around key issues that determine product quality, functionality or schedule; you will lead development of scenarios and alternatives that can guide strategic decision making.

• You will decide on project execution priorities and technical approach in accordance with cross-functional evaluation and risk assessment; you will develop project plans and direct execution in line with approved budgets, timelines, risk mitigation plans, and resources.

This role is on-site in Carlsbad, CA.
There are no relocation benefits for this role.

Who You Are:
(Required)

• You have a Ph.D. degree in Biochemistry, Chemistry, Microbiology, Molecular Biology, Biomedical Engineering, or related field with 15+ years of experience in medical diagnostic product development 

• You have 10+ years of leadership experience managing large scientific teams within the diagnostics/assay development space.

• You have a proven track record of numerous successful product launches.