Current Openings

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:

  • Quality Assurance Computer Systems Specialist
  • Regulatory Affairs Specialist / Manager
  • Genetic Counselor
  • Variant Review Analyst
  • Field Technical Scientist
  • Field Specialist
  • NGS Technologist

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.

Quality Assurance Computer Systems Specialist

Genosity is seeking a qualified individual with the ability to work in a highly cross-functional environment. In this position, the QA Computer Systems Specialist will manage Genosity’s effort in implementing and maintaining quality activities pertaining to systems validation in a GxP environment.

Specific responsibilities include:

  • Manage the qualification or the validation (as applicable) of laboratory information systems
  • Participate to the qualification of third-party vendors as 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 clients validation effort with respect to SaaS implementation
  • Participate to incident review with SaaS Technical team. Carry out root cause analysis and follow the 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 and 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 Systems 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 ISO 27001, 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

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.

Genetic Counselor

Genosity is seeking a highly-motivated, detail-oriented counselor to join our team.  This individual will be responsible for drafting clinical reports and communicating genetic testing results to Genosity clients when needed.  Candidates should have a good understanding of NGS diagnostic testing.

Specific responsibilities include:

  • Interpret NGS results in clinical contexts using concise language
  • Review and summarize medical genetic diagnosis, etiology, inheritance patterns, and risk of occurrence and reoccurrence
  • Compose patient reports in a timely manner
  • Recommend genetic testing to patients and families as needed
  • Prepare and submit Genosity abstracts, publications, and posters
  • Train and onboard other genetic counselors
  • Support variant review analysts and geneticists on R&D and technical projects related to Genosity laboratory services when needed
  • Coordinate between different contacts internally, ordering physicians, and clients in order to ensure seamless transitions throughout the counseling process
  • Coordinate between different contacts internally, with our partners, and clients in order to ensure seamless transitions throughout the implementation process when needed

Qualifications:

  • Bachelor’s degree in human genetics, health sciences or a related degree
  • ABGC certification or active candidate status required
  • Demonstrated ability to communicate and comprehend medical diagnoses
  • Excellent written and oral communication skills

Variant Review Analyst

Genosity is seeking a highly-motivated, detail-oriented, technology-savvy scientist to join our laboratory team.  This individual will be responsible for NGS result quality control, analysis, and interpretation.  Candidates should understand the complexities of NGS data review.

Specific responsibilities include:

  • Conduct sample and variant analysis quality control
  • Review NGS results for clinical cases using standard operating procedures
  • Classify variants through literature review and available resources
  • Summarize variant interpretation using concise language
  • Support genetic counselors and geneticists on R&D and technical projects related to Genosity laboratory services
  • Ensure seamless transitions throughout the analysis and implementation process by coordinating communications between internal contacts, partners and clients.

Qualifications:

  • PhD degree in the life sciences
  • 1+ years of relevant work experience in the genomics arena
  • Demonstrated ability to communicate and comprehend complex scientific and medical topics

Field Technical Scientist

Genosity is seeking a highly motivated and technology-savvy scientist to join our growing team to provide support, management and outreach for Genosity’s products, services and operational capabilities.

Specific responsibilities include:

  • Educate healthcare professionals on the company’s software portfolio
  • Function as a scientific and technical resource and work to match customer needs with available resources
  • Assist the Commercialization Team in client demonstrations related to initial sales calls
  • Gather client specifications during initial project scoping and ongoing use of the system
  • Provide training to clients on use of the Genosity software
  • Perform internal testing of the system with appropriate documentation during User Acceptance Testing and/or system updates
  • Support clients on technical projects related to Genosity’s consultation services as determined by supervisor
  • Support clients with other consultation services, such as drafting validation plans
  • Assist the Commercialization Team with technical documentation and user guides
  • Train clients on various assays and provide wet lab technical support
  • Coordinate between different contacts internally, with our partners, and clients in order to ensure seamless transitions throughout the implementation process
  • Ensure the appropriate dissemination of transparent, fair-balanced scientific and clinical information, knowledge and services in a timely, compliant, ethical and customer-focused manner

Qualifications:

  • Master’s in clinical laboratory science, biological science, computational biology or biotechnology with 2 years of relevant experience in a commercial/industry setting; OR Bachelor’s in clinical laboratory science, biological science, computational biology or biotechnology with 4 years of relevant experience in a commercial/industry setting
  • A minimum of two years of experience in a customer support role with direct client interaction
  • Ability to multi-task and work independently
  • Technical knowledge in the genomics/molecular biology arena is strongly preferred
  • A well-established network in the genomics or oncology space across academic centers and pharmaceutical companies is strongly preferred
  • Demonstrated ability to comprehend complex scientific, medical, and emergent business issues
  • Successful record of managing large and complex projects with minimal oversight
  • Strong interpersonal and communication skills, both oral and written

Field Specialist

Genosity is seeking a qualified individual to join our team to grow sales of our products and services.

Specific responsibilities include:

  • Grow revenue and expand territory into new accounts by following up on leads, cold calling, meeting with customers and prospects regularly, writing quotes and price lists, negotiating contracts
  • Develop and implement an effective territory business growth plan
  • Drive the marketing process for the territory by creating a marketing plan, registering/planning/ attending local vendor shows
  • Develop and present personalized sales presentations to professional audiences
  • Establish positive long-term client relations through scheduling and conducting calls with clients.
  • Develop and maintain a full business pipeline of prospective clients and assume all territory management in an assigned geographic region.
  • Maintain knowledge of competitors and their presence in assigned territory

Qualifications:

  • Bachelor’s Degree required (Biology or Life Sciences preferred), background in Molecular Biology preferred
  • 4-5 years of selling genomic products and/or services to Bio-pharmaceuticals and/or Academic centers desired
  • Experience in cold calling and breaking territory required
  • Strong communication and interpersonal skills, both oral and written
  • Willing and able to travel overnight as required (25-50% travel depending on sales territory and position)

NGS Technologist

Genosity is seeking a highly motivated and technology-savvy scientist to join our laboratory team. This individual will be charged with implementing new next-generation sequencing assays as well as 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 variety of routine and non-routine laboratory experiments including DNA/RNA isolation, NGS library preparations and sequencing using various techniques and 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; documents all quality control activities, instrument and procedural calibrations, reagent preparation and testing, and instrument maintenance performed.
  • Take initiatives 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 NGS lab operations
  • Extensive hands-on, state-of-the-art molecular biology experience
  • Track-record of working with novel NGS assays
  • Strong interpersonal and communication skills, both oral and written

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

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