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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 provider of diagnostics, the Roche Group offers an unrivaled experience in developing and commercializing tests that enable personalized treatment strategies for patients. 

As a member of our R&D team, the Manager, Assay Development will lead a team of research associates and scientists to drive innovation and development of best solutions to support clinical study needs. The manager will take ownership of project deliverables and facilitate the decision-making process with well-considered tradeoffs. In addition, this individual will partner and lead closely with internal scientists and external partners; will work cross-functionally to drive product, process, and tool improvements to ensure fact-based scientific, development, and analytical best practices and principles are utilized.

You will manage multiple projects to develop supporting molecular assays for future cobas® ePlex products.  

You will maintain organizational focus and expertise on best practices and scientific excellence.

You will work closely with the Clinical, Regulatory and Quality teams for successful clinical studies, regulatory submissions and design control processes.

You will lead the transfer of assay methods to clinical study partners for validation.

You will build and provide leadership for a high functioning team including hiring, on-boarding, developing, goal setting, performance improvement and disciplinary actions. 
 

Who You Are:
(Required)

You have a Bachelor’s in Biochemistry, Microbiology, Molecular Biology, Bioengineering, Biomedical Engineering (or equivalent) and 10+ years of direct industry experience in nucleic-acid based diagnostic assay development in infectious disease diagnostics.; or a Masters/PhD in Biochemistry, Microbiology, Molecular Biology, Bioengineering, Biomedical Engineering (or equivalent) and 6 years of direct industry experience in nucleic-acid based diagnostic assay development in infectious disease diagnostics.

You have a minimum of three years experience (working knowledge) of comparator and discordant testing requirements to support clinical studies.

You have demonstrated technical expertise in the design and development of multiplex PCR, Sanger Sequencing, and NGS, including bioinformatics, assay design, and analysis of complex data sets

You have demonstrated expertise in Design Control methodologies; including in-depth technical design understanding  of molecular biology methodologies applied to detection of infectious diseases

You have demonstrated leadership experience as a core team leader or technical lead on product development projects; you have in-depth knowledge of the product development process –  with demonstrated success in leading multiple product development projects from feasibility to launch 
 

Preferred:

You have the experience to build authority and accountability within a team, with strong collaboration and communication skills.

You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities; you have the ability to formulate and solve problems; you complete work in a timely, accurate and thorough manner

You have demonstrated experience as a proactive leader, with a strong sense of urgency, discipline, and commitment to commercializing new products and achieving company objectives.

Demonstrated experience performing verification and validation on molecular assays. 

Demonstrated experience in transfer of technologies to external partners.
 

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 is an on-site position based in Carlsbad, CA. (This is not a hybrid position.) 

Relocation benefits are not available for this position. 

The expected salary range for this position based on the primary location of Carlsbad, CA is $112,000 - $208,000. 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

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.