Sr Scientist, Assay Development

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The Position

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

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.

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, the Senior Scientist will partner and lead closely with internal scientists, engineers, and external partners to develop protocols for microfluidic consumable and assay development; will work cross-functionally to drive product, process, and tool improvements to ensure fact-based scientific, engineering, and analytical best practices and principles are utilized. This individual 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. You will plan, execute, and analyze cutting edge technologies that will lead to the development and integration of new molecular diagnostic assays and manufacturing process improvements and create the next generation of syndromic molecular diagnostics. 

• You will work cross-functionally as a hands-on technical leader to develop new IVD products.

• You will perform early development on new technologies for future platforms.

• You will lead, manage, and organize projects and junior-level staff and track deliverables.

• You will lead within a multidisciplinary project team to integrate assays into current and future platforms.

• You will independently identify, invent, and (internally) develop new molecular biology methods and technologies (e.g., nucleic acid extraction chemistries for multiple sample types) for assay and product development.

• You will supervise multidisciplinary system characterization activities of current and future platforms.

• You will supervise drafting and publishing of data summaries, reports, regulatory documentation, SOPs, and procedures to be presented to internal and external stakeholders.

• You will effectively communicate experimental results and propose new strategies and methods to address immediate and upcoming technical issues to multiple stakeholders.

Who You Are:

(Required):

• You have a Ph.D degree in the Molecular Biology, Biochemistry, Microbiology (or related discipline) with 3+ years of professional product development experience after graduation; or a Masters in the Molecular Biology, Biochemistry, Microbiology (or related discipline) with 4+ years of professional experience after graduation; or a BS in the Molecular Biology, Biochemistry, Microbiology (or related discipline) with 6+ years of professional product development experience after graduation.

• You have demonstrated experience 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:

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

• 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.