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.
• You have demonstrated knowledge in late-stage development and product transfer activities for IVDs, preferably for unit-use or point-of-care consumable devices
• You have demonstrated experience working with various health authorities, including the FDA; have made significant contributions to the successful clearance of an FDA regulated medical device.

Preferred:

• You have demonstrated ability to understand complex scientific, engineering and business concepts
• You have demonstrated experience collaborating with cross-functional teams; creating and maintaining project plans, budgets and schedules
• You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities
• You have strong written and verbal communication skills; including the ability to communicate with all levels within the organization.
• You have experience working collaboratively, fostering professional and constructive relationships as part of a team; while also working independently to produce data and meet challenging timelines and goals

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment. While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

This position is based in Carlsbad, CA.

Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of Carlsbad, CA is $196,200 - $364,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.

Benefits

Who we are

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark's ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.