Current Openings

Sr. Scientist, Bioinformatics

Genosity is seeking a qualified individual to join our growing team to support projects related to the analysis of next-generation sequencing (NGS) data. This individual will be charged with software development for a variety of scenarios in a high-throughput environment, including exome, genome and RNA sequencing for germline as well as somatic applications. Work will involve utilizing existing industry-standard genomics tools as well as developing new algorithms. The selected candidate will work alongside scientists and our team of developers. They will additionally assist with project documentation and ongoing support of clients.

Specific responsibilities include:

  • Rapid prototyping of novel algorithms
  • Develop best practices for analysis of NGS data including optimization of parameters, and consensus approaches across various tools
  • Benchmark the Genosity toolkit in various competitions and challenges
  • Work closely with the other staff to identify gaps in variant detection and annotation algorithms in current pipeline
  • Maintain a high profile in the NGS and Bioinformatics community through publications, conference presentations and collaborations
  • Develop and or apply machine learning techniques to improve variant pathogencity prediction algorithms.

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.

Qualifications:

  • BS or MS in Bioinformatics, Computer Science, Engineering or a related field
  • 4+ years professional bioinformatics development experience
  • Proficiency in at least two major scripting languages (Perl/Python, R, Java, etc) and Unix/Linux shell
  • Familiarity with processing NGS or other high-throughput genomic data, plus publicly available genomics tools and data repositories such as ClinVar, Exome Variant Server, 1000 Genomes, TCGA and DGV.
  • Experience in bioinformatics resources and tools such as BLAST, BWA, GATK, dbGaP, Clustalw, NCBI, EBI, Pfam, COG, GO, KEGG, etc.
  • Demonstrated ability to work both independently and in a team environment
  • Demonstrated problem solving and communication skills

Benefits:

  • Health, dental, vision
  • Casual environment
  • Opportunity to experience start-up culture

Please send your resume to info@genosity.com to apply for this position.

Regulatory Affairs Manager

Genosity is seeking a qualified individual to join our growing team and support the regulatory needs of our technology offerings in Next Generation Sequencing and Genomics. This individual will lead Regulatory Affair activities within the organization and work with scientists, laboratorians and executive management to interface with regulatory authorities on all related activities. This role will have the unique opportunity to manage the intersection of clinical laboratory and FDA regulations in the rapidly growing field of diagnostic next generation sequencing.

Specific responsibilities include:

  • Track and manage all clinical laboratory regulatory requirements per CLIA, NYS and CAP.
  • Ensure that all clinical laboratory licenses accreditations are kept updated and current.
  • Develop, organize and maintain regulatory documents associated with submissions, projects, inspections and audits.
  • Contribute to quality control and regulatory strategies for the organization.
  • Execute internal regulatory strategies and manage monthly quality meetings.
  • Attend client meetings on projects as regulatory representative as needed.
  • Draft and review validations, quality documentation and change control documentation.
  • Develop documents to be included in submissions, which may include validation protocols and reports and/or software documentation.

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.

Qualifications:

  • MS or PhD with 1-2 years or BS with 2-4 years of experience in the diagnostic, biotechnology, medical device, or biopharma industries, at least 1 of which should include regulatory affairs experience.
  • Detailed knowledge of CLIA, CAP, NYS and FDA regulations.
  • Must have experience in maintaining clinical laboratory licensure and accreditations.
  • Experience with regulatory submissions and audits and or inspections.
  • Demonstrated ability to work both independently and in a team environment
  • Scientific background in molecular biology and understanding of NGS technologies.
  • Must understand and have experience with clinical laboratory operations.
  • Superior technical writing skills.
  • Must be detail oriented with excellent prioritization and organizational skills.
  • Must be able to deliver results on schedule in a fast-paced, dynamic environment.

Benefits:

  • Health, dental, vision
  • Casual environment
  • Opportunity to experience start-up culture

Please send your resume to info@genosity.com to apply for this position.

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

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