Senior Staff Scientist, Research & Development

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

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 provider of companion diagnostics, 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 team, the Senior Staff Scientist will define and execute multiple product improvements to meet customer needs, address internal needs such as manufacturing process improvements, and other product lifecycle scientific needs and may help develop next generation products. In addition, the Senior Staff 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.

• You will maintain and advance the broad knowledge of principles, best practices and literature in molecular biology, assay integration, protein / enzyme analytical sciences and bioengineering / consumables functionality.

• You will manage, evaluate and approve complex design changes across multiple disciplines to ensure customer and internal requirements are met

• You will create partnerships with RA/QA to ensure compliance to applicable legal and regulatory standards and build collaborative partnerships with local GenMark staff and with global teams at Roche

• You will design, conduct and direct complex experiments and characterization studies for assay conditions and material variables, with consideration for critical to quality attributes

• You will design multifactorial experiments on and off cartridge and consumables to troubleshoot and resolve failure modes 

• You will conceptualize and develop analytical methodologies to aid product characterization and process development, for critical parameter management

• You will optimize existing or develop new molecular diagnostics assays.

• You will lead Engineering Change Orders, such as BOM, SPECs, Manufacturing work instructions; you will be responsible for data processing, graphing, design of experiments (DOE), and statistical analysis (ANOVA)

Who You Are:
(Required)

• You have a Ph.D degree in the Life Sciences, Physical Sciences, BioEngineering (or related discipline) with 8+ years of professional product development experience after Ph.D/Post Doc

• You have demonstrated experience in IVD/FDA regulated, clinical diagnostics, reagent or consumable, molecular biology tools product development with a track record of successful product launches with a proven track record of multiple product optimization through design of experiments (DOE)

• You have demonstrated knowledge of sample prep and amplification methods; experience with assay integration or assay automation and software analysis; experience partnering with operations transfer / process development teams.

• You have demonstrated experience in test protocol development, execution and reporting including developing accelerated and real time stability protocols.

• You have a demonstrated level of expertise in: IVD/Diagnostics; Design Control; QMS; Molecular Biology expertise for RNA and DNA assays; BSL II experience, infectious disease testing

• You have leadership experience in a matrixed environment; demonstrated ability to coach and influence others; you have effective analytical problem solving, judgment and decision making skills; you have the ability to read, write and analyze complex documents

Preferred:

• You have experience with various DOE tools (JMP or R preferred)