Manager, 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 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