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:

  • General Laboratory Supervisor
  • Technical Laboratory Supervisor
  • Regulatory Affairs Specialist / Manager
  • 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.

    General Laboratory Supervisor

    Genosity is seeking highly motivated and qualified individual to supervise technical personnel and report findings, perform tests requiring special scientific skills, and, in the absence of the director, be responsible for the proper performance of all laboratory procedures. Interviews are prioritized for individuals willing to work evening shifts (1pm-9pm) and/or Saturdays.  An inability to work these hours does not disqualify potential candidates. The General Laboratory Supervisor reports to the Laboratory Operations Manager.
    Specific responsibilities include:
    • Overseeing the day to day operations of the laboratory, including:
      • Ensuring all testing personnel are trained and competent in accordance with company policies and that such activities are documented
      • Establishing and maintaining a calendar of activities
      • Performing training and routine competency assessment of testing personnel in areas where the General Supervisor is competent
      • Management of laboratory technician and technologists
      • Managing reagent and consumable inventory, ensuring that reagent performance evaluations are completed, that staff is only using verified reagents in clinical testing, and performing documentation of reagent performance verifications
      • Enforcing quality standards
      • Ensuring instrumentation is functioning properly, maintenance is being performed and associated documentation is complete and reviewed in a timely manner
      • Ensuring all laboratory equipment is managed in accordance with laboratory policies and procedures
      • Ensuring all quality management activities are being performed on time and properly documented
      • Ensuring testing personnel are following the approved policy and procedures
      • Ensuring the test activity menu is up-to-date, and with the Quality Assurance Department, ensuring outside regulatory agencies are aware of changes to the test activity menu
      • With the Technical Supervisor and Laboratory Director, managing the laboratory temperature monitoring system including timely response and documentation to alerts and alarms
      • Preparing monthly reports related to quality metrics for the temperature monitoring system
    • Working with Technology Development staff to develop, transfer and validate new tests
    • Implementing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance, ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results
    • Aggregating and reviewing monthly laboratory key performance indicators to be reported during quality assurance meetings
    • Performing responsibilities delegated from the Laboratory Director:
      • Assuring remedial action is taken whenever test system results deviate from established specifications
      • Ensuring test results are not reported until all corrective action has been taken and the test system is functioning properly
      • Ensuring new lots or new shipments of existing lots have successful performance evaluations prior to routine use
    • Improving operational efficiency of production assays and processes in collaboration with Technology Development Team under the Laboratory Director’s guidance
    • Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications
    • Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed
    • Verifying that testing personnel are evaluated semi-annually during the first year of hire, and thereafter annually, as being competent for assigned tasks, and that remedial action is performed when staff do not perform as expected
    • Creating an annual PT testing schedule and ensures new tests are enrolled within 6 months of launch and all PT testing is initiated in accordance with the schedule
    • Delegating of responsibilities to senior technical staff
    • Working with the Laboratory Director and Technical Supervisor to address audit findings and Non-Conforming Events in a timely manner.
    Qualifications:
    • Doctorate in clinical laboratory science or chemical, physical or biological science and 2 years training and experience in high-complexity testing; OR
    • Master’s in clinical laboratory science, medical technology or chemical, physical or biological science and 4 years training and experience in high-complexity testing; OR
    • Bachelor’s in clinical laboratory science, medical technology or chemical, physical or biological science and 6 years training and experience in high-complexity testing
     

    Technical Laboratory Supervisor

    Genosity is seeking a highly motivated and qualified individual to supervise technical personnel and report findings, perform tests requiring special scientific skills, and, in the absence of the director, be responsible for the proper performance of all laboratory procedures.  This individual will perform testing activities as needed based on laboratory testing staff availability, relying on experience and judgment to plan and accomplish goals. Interviews are prioritized for individuals willing to work evening shifts (1PM-9PM) and/or Saturdays.  An inability to work these hours does not disqualify potential candidates. The Technical Laboratory Supervisor reports to the Laboratory Operations Manager
    Specific responsibilities include:
    The Technical Supervisor may function as a General Supervisor simultaneously. They must provide technical supervision monitor test analyses and specimen examinations to ensure that acceptable levels of analytical performance are maintained.
    • Investigation of new testing methods, including:
      • Testing of new kits or technologies, reagents and protocols
      • Selecting test methodologies that are appropriate for the clinical use of the test results
      • Optimization of assay protocols prior to validation
      • Participation in the development and review of new or updated assay protocols
      • Development of automation workflows for appropriate assays
    • Working with the General Supervisor and appropriate staff to validate new assays
    • Working with the General Supervisor to train testing personnel on new assays or updates to existing assays
    • Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications
    • Identifying training needs with the General Supervisor and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services perform
    • Performing responsibilities that were delegated from the Laboratory Director:
      • Assuring remedial action is taken whenever test system results deviate from established specifications
      • Ensuring test results are not reported until all corrective action has been taken and the test system is functioning properly
      • Providing orientation and training to testing personnel and evaluating competency of the staff at 6 months and 12 months
      • Reviewing and approving change control requests designated as minor in category
    Qualifications:
    • Doctorate in clinical laboratory science or chemical, physical or biological science and 2 years training and experience in high-complexity testing; OR
    • Master’s in clinical laboratory science, medical technology or chemical, physical or biological science and 4 years training and experience in high-complexity testing; OR
    • Bachelor’s in clinical laboratory science, medical technology or chemical, physical or biological science and 6 years training and experience in high-complexity testing
     

    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.
     

    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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