Sr. Scientist - Assay Development

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GenMark, a member of the Roche Group, is dedicated to providing world-class solutions for multiplex testing, with enhanced features that contribute to Roche's commitment to helping diagnose infectious diseases and reduce antibiotic resistance. As the world's #1 diagnostics provider, the Roche Group offers an unrivaled experience in developing and commercializing predictive tests that enable personalized treatment strategies for patients.

This is an on-site in Torrey Pines, CA. Ability to travel between GenMark's main Carlsbad, CA headquarters is required.

As a member of our R&D Assay Technology Development team, the Senior Scientist will identify and develop next generation innovations for on-market and future platforms. In addition, you will partner and lead closely with internal scientists, engineers, and external partners to develop protocols for microfluidic consumable and assay development. Your work cross-functionally to drive product, process, and tool improvements to ensure fact-based scientific, engineering, and analytical best practices and principles are utilized.

You will be responsible for identifying, developing, and inventing new molecular biology technologies for highly multiplexed molecular IVD products. You possess strong technical knowledge and practical experience in developing state-of-the-art molecular biology tools (e.g. nucleic acid extraction chemistry from multiple sample types, nucleic acid amplification technologies (NAAT), isothermal amplification, gene editing, CRISPR, Fanzor, protein engineering, etc.) to build highly multiplexed molecular IVD products.

Also, in this role you are:

• Planning, executing, and analyzing cutting-edge technologies that will lead to the development and integration of new molecular diagnostic assays and manufacturing process improvements, and creating the next generation of syndromic molecular diagnostics.
• Working cross-functionally as a hands-on technical leader to develop new IVD products.
• Performing early development on new technologies for future platforms.
• Leading, managing, and organizing projects and junior-level staff, and tracking deliverables.
• Leading within a multidisciplinary project team to integrate assays into current and future platforms.
• Independently identifying, inventing, and internally developing new molecular biology methods and technologies (e.g., nucleic acid extraction chemistries for multiple sample types) for assay and product development.
• Supervising multidisciplinary system characterization activities of current and future platforms.
• Supervising drafting and publishing of data summaries, reports, regulatory documentation, SOPs, and procedures to be presented to internal and external stakeholders.
• Effectively communicating experimental results and proposing new strategies and methods to address immediate and upcoming technical issues to multiple stakeholders.

• You have a PhD degree in Molecular Biology, Biochemistry, Microbiology (or related discipline) with 3+ years of professional product development experience after graduation; or a Masters in Molecular Biology, Biochemistry, Microbiology (or related discipline) with 4+ years of professional experience after graduation; or a BS in Molecular Biology, Biochemistry, Microbiology (or related discipline) with 6+ years of professional product development experience
• You will succeed at this position by having an entrepreneurial/startup mentality and working cross-functionally to investigate new technologies, ideate solutions, and implement ideas into on-market and new products.
• You have extensive experience in IVD product development, expert knowledge of new technologies, and have a problem solving mindset.
• You possess mastery in data analysis, research design, bioinformatics, and application of new techniques is necessary.

Preferred behaviors, competencies, and qualities of the ideal applicant.

• A PhD in the Molecular Biology, Biochemistry, Microbiology (or related discipline), along with 3+ years of relevant industry, product development experience is preferred.

• For those with a Bachelor's, you have 16+ years of relevant industry (product development) experience within the diagnostics space; for those with a Masters, you have 14+ years of relevant industry (product development) experience within the diagnostics space.

• You have experience with various statistical analysis and DOE tools (JMP or R preferred).

• You have a high level of familiarity with working under a Quality Management System and relevant FDA documentation.

• You have experience with electrowetting movements and/or microfluidics.

• You have the ability to complete work in a timely, accurate and thorough manner; you are able to think and work both tactically and strategically; you are hands-on, self-directed, and organized.

• You have demonstrated communication skills including the ability to communicate with multiple levels within the organization; you have strong presentation and influence skills.

• You have strong time management and organizational skills in a dynamic, constantly changing environment; you have the ability to respond effectively to sensitive inquiries, as well as communicate effectively both orally and in writing with management, peers and individuals.

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.

Relocation benefits are not available for this posting.

The expected salary range for this position, based on the primary location of Carlsbad, CA is $120,000 - $145,000 annually. 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

#genmark2025

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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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