Latest Jobs at 54Gene

Department: Laboratory Operations
Status: Full-Time, Exempt
Industry: Biotechnology

Job Description

• We are seeking a talented Laboratory Director for its Women’s Health division to perform a variety of functions as part of our Clinical Operations team.
• The ideal candidate will have a strong background in clinical testing for noninvasive prenatal testing (NIPT). Initial responsibilities will focus on clinical reporting in these areas that represent core content for NIPT testing.​​

Essential Functions
Roles and Responsibilities:

• Evaluating genomic profiles of NIPT specimens (NGS based)
• Oversee the review of genetic and CNV variant data: interpret NGS and microarray results in the context of medical literature, online variant databases and other references along with relevant patient demographic data.
• Participate in assay development and validation from: sequencing (NGS, pyrosequencing, Sanger), DNA fragment analysis, microarrays, FISH, karyotype, digital droplet PCR)
• Writing, reviewing and signing out reports for clinicians, and advising them on investigation strategies, as needed.
• Interpreting the results of routine and esoteric molecular tests carried out by molecular technologists.
• Developing and devising new testing strategies, primarily in NIPT, but other fields as needed.
• Working closely with the IT department in maintaining and continuously improving the clinical database of genomic information (in-house and publicly/privately available).
• Oversees CLIA/CAP level validation of new molecular assays.
• Training and teaching staff, colleagues and other health care professionals.
• Maintaining and interpreting quality control and quality assurance data.
• Continually updating professional skills and knowledge by following the most recent scientific literature and attending training courses and conferences and participating in publication and research activities of the Company.
• Fulfill laboratory director responsibilities as defined by CAP
• Ensure quality and compliance standards including an effective quality management program for the laboratory, PT testing an corrective actions
• Establish and ensure quality assessment and quality control programs are established and maintained
• Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained

Supervisor Responsibilities:

• Supervise Clinical and Lab staff as required for assigned tasks and projects 

Environment / Safety / Work Environment:

• General office environment.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
• Maintains a clean, neat, and orderly work area
• Adheres to Department Specific Safety Guidelines

Physical Demands:

• Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 10-20 pounds

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

Requirements
Qualifications, Knowledge, Skills & Abilities:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 
• The requirements listed below are representative of the knowledge, skill, and/or ability required. 
• Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. ABMG certification in LGG, Clinical Molecular Genetics:
  • Knowledge of ACMG variant interpretation guidelines and ISCN nomenclature
  • Familiarity with  CAP and CLIA compliance requirements 
  • Basic computational or bioinformatic skills strongly preferred
  • Ability to balance and manage multiple tasks and projects independently in a fast-paced, matrixed environment

Education & Certifications

• M.D. or Ph.D. and ABMG certification in LGG, Cytogenetics and Molecular Genetics or ABMG/ABP certification in Molecular Genetic Pathology
• At least 2 years of experience in a clinical laboratory setting

Experience:

• Experience leading a laboratory offering prenatal screening and oncology testing and evaluating, interpreting, and reporting out NGS and microarray data
• Familiarity with next-generation sequencing, and/or knowledge of advanced methods of copy number detection
• Strong background in human and medical genetics, and cytogenetics with a familiarity of online human genomics
• Understanding of statistical measures utilized in genetic testing and screening
• Experience with clinical regulatory requirements including CLIA and CAP
• Experience working in a multidisciplinary team and managing a clinical lab team
• Desired educational background
• Certifications

Other

• Willingness to travel to Nigeria at least once a year.

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Department: Laboratory Operations
Status: Full-Time, Exempt
Industry: Biotechnology

Job Description

• We are seeking an organized, diligent, board eligible/certified Clinical Molecular Geneticist or Molecular Pathologist.
• This position is directly responsible for developing and using genetics and molecular biology techniques to identify potentially targetable alterations in the tumors, and in addition to examine inherited conditions such as cancer predisposition syndromes, and other heritable conditions.

Essential Functions
Roles and Responsibilities:

• Evaluating genomic profiles of tumor specimens (NGS based)
• Participate in assay development and validation from RNA and DNA including: sequencing (NGS, pyrosequencing, Sanger), DNA fragment analysis
• Writing, reviewing and signing out reports for clinicians, and advising them on investigation strategies, as needed
• Interpreting the results of routine and esoteric molecular tests carried out by molecular technologists
• Developing and devising new testing strategies, primarily in oncology, but other fields as needed
• Working closely with the IT department in maintaining and continuously improving the clinical database of genomic information (in-house and publicly/privately available)
• Oversees CLIA/CAP/ASCO-level validation of new molecular assays
• Training and teaching staff, colleagues and other health care professionals
• Maintaining and interpreting quality control and quality assurance data
• Continually updating professional skills and knowledge by following most recent scientific literature and attending training courses and conferences and participating in publication and research activities of the Company
• Fulfill laboratory director responsibilities as defined by CAP
• Ensure quality and compliance standards including an effective quality management program for the laboratory, PT testing and corrective actions
• Establish and ensure quality assessment and quality control programs are established and maintained
• Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained

Supervisor Responsibilities:

• Supervise Clinical and Lab staff as required for assigned tasks and projects 

Environment / Safety / Work Environment:

• General office environment.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
• Maintains a clean, neat, and orderly work area
• Adheres to Department Specific Safety Guidelines

Physical Demands:

• Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 10-20 pounds

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

Requirements
Qualifications, Knowledge, Skills & Abilities:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 
• The requirements listed below are representative of the knowledge, skill, and/or ability required. 
• Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. ABMG certification in LGG, Clinical Molecular Genetics.
• Knowledge of ACMG variant interpretation guidelines
• Familiarity with  CAP and CLIA compliance requirements 
• Basic computational or bioinformatic skills strongly preferred
• Ability to balance and manage multiple tasks and projects independently in a fast-paced, matrixed environment

Education & Certifications

• M.D. or Ph.D. and ABMG certification in LGG, Clinical Molecular Genetics or ABMG/ABP certification in Molecular Genetic Pathology

Experience:

• At least 2 years of experience in a clinical laboratory setting
• Significant experience in somatic molecular genetic testing, including Next  Generation Sequencing (NGS) technologies, with knowledge of, and experience with, classifying and interpreting somatic genetic variants
• Experience with clinical regulatory requirements including CLIA and CAP
• Experience working in multidisciplinary team and managing a clinical lab team

Other:

• Willingness to travel to Nigeria at least once a year