Current Openings

Genosity is a biotechnology company focused on providing tools and services for genomic clinical research applications. Our mission is to unlock the power of precision medicine to improve patient care by providing a technology platform to advance genomics and facilitate collaborative research. At Genosity, you will have the opportunity make your mark at a rising startup company, while working in the NGS and clinical laboratory spaces.  Our current position openings include:

  • Senior Dev Ops Engineer – Fully Remote
  • Bioinformatics Scientist
  • Field Application Scientist
  • Regulatory Affairs Specialist / Manager
  • Quality Assurance Computer Systems Specialist
  • Research Associate I
  • Genomics Technologist I
  • To apply for these positions, please send your resume and cover letter to HR@genosity.com.  All positions include access to health, dental, and vision benefits.  All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability.

    Senior Dev Ops Engineer – Fully Remote

    Genosity is hiring an US-based, full-time senior DevOps engineer to transition our SaaS genomics platform to an in-house operations team. Your team will be responsible for running user-facing services and production systems, helping to build the foundation for rapid, reliable product delivery. Your team will instill best practices for building scalable distributed systems, with a focus on observability, automation, auditability, and fault tolerance. You should be a very experienced cloud engineer and architect, able to hit the ground running with little oversight and minimal support from the existing team. AWS, Terraform, architecture, and hands-on experience with the software development lifecycle are required. This position is fully remote (even after COVID) with no travel required.  If you’d prefer an office, you can work out of ours in Iselin, NJ.

    Specific responsibilities include:
    • Help hire, mentor, and scale the DevOps team.
    • Architect a scalable software delivery pipeline (CI/CD) for SaaS genomics software and the processes, people, tooling, infrastructure to support it.
    • Run our existing infrastructure built with Terraform and Kubernetes.
    • Design, build and maintain core infrastructure that scales to meet market demand.
    • Build, maintain, and support our AWS resources, monitoring costs and suggesting optimizations.
    • Shape security policies to meet compliance and regulatory requirements, triage issues.
    • Automate deployment of development, testing and production environments, collaborating with development team to make deployments fast and efficient.
    • Communicate with business leadership about infrastructure opportunities.
    • Build a monitoring stack and instrumentation to alert on symptoms and not on outages.
    • Define a new local build process for our software stack.
    • Monitor and respond to production and development issues across the full stack.
    • Build an on-call rotation plan for the engineering organization.
    Qualifications:
    • Based in the US
    • Well versed with AWS, Terraform, Linux, open source software, and systems/software/cloud architecture
    • Hands-on SDLC experience
    • Technical knowledge of the following systems:
      • AWS services: Cognito, EC2, ES, RDS Postgres, Codecommit, ECR, R53, KMS, CloudTrail, CloudWatch, S3
      • Databases: Cassandra, Blazegraph, RDS Postgres, S3, Elasticsearch and ELK full stack
      • Docker, Kubernetes (not EKS), kops, Helm, Grafana, Prometheus
      • Iguana HL7 Integration Engine, Gitlab self-hosted CE, Ansible, Make, Python, Luigi, Kafka, Jenkins
      • Java, Gradle, Maven, Nexus, Artifactory
    • HIPAA, CAP, CLIA knowledge preferred
    • Bioinformatics, genomics, medical/clinical research, data science, and other experiences preferred
    • Occasionally flexibility to coordinate with outsourced development during their shift from 2AM to 11AM EST is helpful
    • Knowledge of the Russian language would be helpful to work directly with the outsourced team and read their internal documentation
    • This is a fully remote position with no travel required – but if you happen to be convenient to New Jersey, the team would love to meet occasionally!
     

    Bioinformatics Scientist

    Genosity is seeking a Bioinformatics Scientist to join our team.  This role will be centered around developing tools and pipelines that facilitate smooth business operations around multiple projects.  The Bioinformatics Scientist will help develop systems for the efficient management of clinical and non-clinical data, and be an interface to internal and external stakeholders. The Bioinformatics Scientist must be skilled in programming and be able to solve common and complex bioinformatics problems. The ideal candidate should be able to perceive a problem clearly and dissect it into components which can be resolved programmatically.  Having a fundamental grasp of genomics will be key to succeeding in this role. The candidate should be independent, well-organized, collaborative, have excellent communication skills, and be able to frequently switch between tasks. The Bioinformatics Scientist will report to the Head of Bioinformatics and Data Sciences.

    Specific responsibilities include:
    • Performing routine NGS data analysis, such as summarizing data, creating reports, and developing scripts and programs that will facilitate operational needs
    • Assisting in system building for data management to enable swift operation of project-specific workflows
    Qualifications:
    • BS in Bioinformatics or Computational Biology (MS preferred)
    • 2+ years experience
    • Fluent in R, *nix, and SQL for data analysis
    • Strong knowledge of Genomics and Molecular Biology
    • Solid understanding of Illumina sequencing technologies and metrics
    • Understanding of Cloud Computing (preferred)
     

    Field Application Scientist

    Genosity is seeking a qualified individual who will be responsible for supporting the implementation of software tools for Genosity clients and providing direct technical support. The Field Application Scientist reports to the Chief Commercial Officer.

    Specific responsibilities include:
    • Assisting the Commercial Team in demonstrating the comprehensive software platform to current and potential customers
    • Providing training to clients on use of Genosity clinical laboratory software
    • Leading software demonstrations and customer engagement at company events, such as tradeshows, webinars, etc.
    • Managing the software support desk and ensuring timely resolution of issues
    • Serving as the technical lead to gather client specifications during initial project scoping and ongoing use of the system
    • Performing internal testing of the system using the appropriate documentation methods for system updates and patch releases
    • Supporting clients on technical projects related to Genosity’s consultation services as determined by the supervisor
    • Supporting clients with other consultation services, such as drafting validation plans, technical documentation, and user guides
    • Training clients on various assays and providing wet lab technical support.
    • Additional responsibilities include those determined by management to support the company’s goals.
    Qualifications:
    • Master’s in clinical laboratory science, biological science, computational biology or biotechnology and 2 years of relevant experience in a commercial/industry setting; OR
    • Bachelor’s in clinical laboratory science, biological science, computational biology or biotechnology and 4 years relevant experience in a commercial/industry setting
    • Minimum of two years experience in a customer support role with direct client interaction
    • Excellent verbal and written communication skills
    • Ability to multi-task and work independently
    • Technical knowledge in the genomics/molecular biology arena is strongly preferred
     

    Regulatory Affairs Specialist / Manager

    Genosity is seeking a qualified individual who will be responsible for the preparation of regulatory submissions required to market new or modified medical devices in the U.S. and related regulatory affairs (RA) activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.

    Specific responsibilities include:
    • Coordinate, prepare, and follow up with FDA Premarket Notification [510(k)] submissions in a timely manner. Act as liaison with FDA regarding product clearance
    • Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission
    • Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions
    • Review/approve label/labeling, promotional and advertising materials to ensure regulatory compliance
    • Review clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance
    • Represent RA in product life cycle development teams by reviewing, approving, and completing requirements
    • Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers
    • Prepare regulatory development plans
    • Prepare meeting packages (e.g. pre-sub meeting.)
    • Interact with FDA and manage regulatory procedures
    • Attend authority meetings
    • Provide interpretation of regulations to project teams and clients (e.g. new guidance impact on ClinOps)
    • Participate in audits as required; oversee follow-up activities and ensure timely implementation and completion of corrective action plans in close cooperation with QA.
    • May contribute to the development and revision of SOPs and standard plans/templates/guidelines to ensure adherence to applicable ethical, regulatory and standards
    Qualifications:
    MUST HAVE MEDICAL DEVICE EXPERIENCE
    • 5 years Regulatory Affairs experience in medical device and in vitro diagnostic device companies or 3 years of experience, plus a Master’s degree.
    • Demonstrated success in taking products through FDA, preferably CDRH.
    • Proficiency with 510(k), sPMA and 21 CFR 820 -Quality System Regulation
    • 10+ years relevant experience, to include demonstrated experience in developing regulatory strategies for drug development, supporting and managing authority interactions, and in developing and writing regulatory documents
    • In-depth working knowledge of ICH guidelines, CFR
    • Experience with medical device, CDx development in other regions, e.g. Canada, EU and Other regulatory aspects of global clinical trials is a plus
    • Strong communication skills including effective verbal, written and presentation skills
    • Strong leadership and interpersonal abilities and organizational skills in a complex and fast paced environment.
    • Ability to reason independently for the purpose of assessing and recommending specific solutions in regulatory drug development.
    • Experience with eDMS is a plus(Greenlight Guru)
    • Proficiency in Microsoft Word, Excel, Outlook and PowerPoint.
     

    Quality Assurance Computer Systems Specialist

    Genosity is seeking a qualified individual who will be responsible for managing Genosity’s efforts in implementing and maintaining quality activities pertaining to systems validation in a GxP environment.  This position requires the ability to work in a highly cross-functional environment.

    Specific responsibilities include:
    • Manage the qualification and the validation (as applicable) of laboratory information systems
    • Participate in the qualification of third-party vendors when their service pertains to information systems
    • Support Genosity’s laboratory risk management program as it pertains to information systems
    • Manage the validation and upgrades of Genosity’s internal LIMS
    • Create/compile the documentation associated with the development, deployment, and maintenance of Genosity’s SaaS in compliance with FDA regulations
    • Perform supplemental research to provide options for compliant solutions to barriers encountered during validation activities
    • Work with QA, IT and Lab Ops teams to ensure that data integrity principles are considered during the requirements and design phase of new projects
    • Participate in data integrity and data governance program
    • Manage the development of Genosity’s QMS for the SaaS in compliance with ISO27001
    • Support Genosity’s client validation efforts with respect to SaaS implementation
    • Participate in incident review with SaaS technical team, carry out root cause analysis, and follow improvement opportunities through to their conclusion
    • Monitor, measure, analyze, and evaluate quality metrics and communicate these outcomes to organizational stakeholders
    • Work with IT team to maintain the catalog of GxP relevant software systems
    • Participate in customer audits as software QA subject matter expert
    • Conduct and document training events
    • Assist with other duties as needed
    Qualifications:
    • Bachelor’s Degree in a technical-related field
    • Minimum of 5 years of experience in pharmaceutical/biotech industry as a validation or qualification project manager in a GxP environment
    • Minimum of 3 years of experience in computer system validation functions
    • Thorough knowledge of FDA and EU regulations as they relate to GLP, GDP, and GMP requirements, knowledge of CSV Part 11, GAMP 5 and data integrity regulations including GDPR
    • Knowledge of, and ability to apply, software oriented world-wide regulatory requirements to insure compliant computer system installation and application operation for both configured and custom systems
    • Managing a QMS for a SaaS is a strong plus
    • Knowledge and experience with ISO27001, ISO9001
    • Knowledge of HIPAA privacy and security rules
    • Experience conducting internal audits, identifying non-conformances, giving feedback, and developing improvement plans
    • Project management background
    • Excellent communication skills, both verbal and written, with the ability to tailor delivery to different audiences
    • Able to multitask efficiently and effectively
     

    Research Associate I

    Genosity is seeking a highly motivated and technology-savvy scientist to join our laboratory team. This individual will be charged with executing R&D projects, providing training, developing new assays, and assisting in troubleshooting new and established assays. Successful candidates must be passionate about wet-lab driven experimentation to find innovative solutions to developmental hurdles.

    Specific responsibilities include:
    • Execute experiments developed in collaboration with supervisor
    • Troubleshoot experiments and formulate testable scientific hypotheses to be discussed with supervisor
    • Maintain documented notes for all experiments performed, as well as for experimental observations, results, interpretations and conclusions
    • Provide ideas and suggestions to improve workflows, techniques and procedures
    • Design and update procedures, validations and training documents for new assays and existing assays as required
    • Provide training for technology transfer to clinical testing staff
    • As required, serve as testing personnel in accordance with CLIA requirements
    • Work with QA department to provide and develop necessary quality documentation upon supervisor’s direction
    • Interact with clients to provide training or consultation services as required
    • Execute research and research service projects
    Qualifications:
    • Master’s degree in a scientific area associated with biology, chemistry, physics with a minimum of 2 years of experience in a related field; OR a Bachelor’s degree in a scientific area associated with biology, chemistry, physics with a minimum of 3-4 years of experience in a related field
    • Minimum of 2 years of experience working in the genomics and technology arena
    • Proficiency in laboratory techniques and genomic-related technology/instrumentation (preferably with NGS and microarrays)
    • Strong troubleshooting and scientific communication skills
     

    Genomics Technologist I

    Genosity is seeking a qualified individual who will be responsible for implementing new next-generation sequencing assays, and running existing validated assays using manual and automated methods, while following established policies and procedures in a professional manner. Successful candidates must be passionate about wet-lab driven experimentation to find innovative solutions to development hurdles.

    Specific responsibilities include:
    • Perform a variety of routine and non-routine laboratory experiments including DNA/RNA isolation, NGS library preparations, and sequencing using various techniques, platforms, and subsequent data analysis
    • Design, set up, and execute experiments to implement new assays in the lab
    • Keep detailed records of high quality, reproducible experiments to share with team and customers
    • Adhere to quality control policies by documenting all quality control activities, instrument and procedural calibrations, reagent preparation and testing, and instrument maintenance performed
    • Take initiative to conceive, design and carry-out hypothesis driven feasibility experiments, understanding both theoretical and practical aspects of the experimental design
    Qualifications:
    • Bachelors or Masters in Molecular Biology or related field
    • 2-4 years of training and/or work experience in genomics lab operations
    • Extensive hands-on, state-of-the-art molecular biology experience
    • Track-record of working with novel NGS and/or microarray assays
    • Strong interpersonal and communication skills, both oral and written
     
    As an EOE employer, Genosity will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, national origin, sexual orientation, gender identity, disability or veterans status.

    GENOSITY
    485F Route 1 South
    Iselin, NJ, 08830
    P: (732) 652-8000
    F: (732) 626-6610
    E: info@genosity.com

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