R&D, Senior Staff Scientist, Consumable Assay Technology

Company: Disability Solutions
Location: Carlsbad
Posted on: November 1, 2024

Job Description:

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 PositionWe 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 10+ years of professional product development experience after Ph.D/Post Doc; or a Masters in the Life Sciences, Physical Sciences, Bioengineer (or related discipline) with 16+yrs of professional experience after graduation; or a BS in the Life Sciences, Physical Sciences, BioEngineering (or related discipline) with 18+ years of professional product development experience after graduation
  • You have successfully developed 5+ multiple, highly complex products and led complex projects leading to commercialization.
  • You have a significant (6-15) publication, patent and product portfolio.
  • 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 documentsPreferred:
    • PhD in the Life Sciences, Physical Sciences, BioEngineering (or related discipline) is preferred.
    • You have experience with various DOE tools (JMP or R preferred)
    • You have experience with electrowetting movements and/or microfluidics
    • You have the ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals
    • 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 skillsWORK ENVIRONMENTThe 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 $121,800 - $226,500. 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.Who we areGenMark 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.

Keywords: Disability Solutions, Hemet , R&D, Senior Staff Scientist, Consumable Assay Technology, IT / Software / Systems , Carlsbad, California