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CooperCompanies · 2 months ago

Staff Scientist, Genomics

3 Regent St., Livingston, NJ, 07039, US

Full-time

Onsite

Senior Level, Lead/Staff

$135K/yr - $180K/yr

5+ years exp

CooperSurgical is a leading fertility and women’s healthcare company dedicated to enhancing the healthcare experience for women and families. They are seeking a Staff Scientist in Genomics to oversee laboratory operations, ensure quality control, and drive improvements in genetic testing methodologies. The role involves hands-on experimentation, data analysis, and collaboration with R&D for new product introductions.

Medical Device

Responsibilities

Technical and scientific oversight of the laboratory including selection of appropriate test methodology

Verification of test procedure analytical performance

Establish and maintain the quality control program including acceptance criteria throughout the entire process from raw material receipt to reporting of test results

Resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from established specifications

Experience in a regulated clinical laboratory environment meeting CLIA/CAP/NYS DOH/ISO 15189/ISO 13485 standards

Perform hands-on, wet lab experiments to evaluate existing genetic testing assays, leading to assay improvements. Use scientific methods and best practices for experimental protocol design, execution, data analysis, and interpretation. Liaise with R&D team to ensure successful new product introduction by employing rigorous validation protocols and methods

Analyze and interpret genetic testing output from data analysis pipelines to assess data quality, support the interpretation of sequencing results, and identify trends for optimization. Aid in troubleshooting and root-cause analysis, and devise solutions and approaches for solving technical problems to improve genetic testing performance in an inclusive and collaborative fashion

Drive technology transfer and implementation of new products or assay improvements. Will include authoring or contributing to development of SOPs, work instructions, etc

Qualification

Molecular biologyGenomicsNext Generation SequencingBioinformatics toolsProcess developmentSOP writingStatistical methodsDocumentation PracticesAdvanced computer skillsAssay optimizationInterpersonal skillsCommunication skillsLeadership

Required

In-depth technical knowledge, proficiency and prior experience with molecular biology, genomics, and associated discipline-specific analytical tools, as well as statistical methods is required

Experience with Sanger and Next Generation Sequencing methods and output required

Experience in process, method, or assay development and optimization with thorough understanding of verification and validation methods is required

Ability to plan activities and lead technical teams or work independently with minimal direction - required

Experience with Good Documentation Practices and ability to maintain detailed records of experiments and outcomes required

Experience writing and authorizing SOPs, test methods, and reports required

Advanced computer skills (Microsoft Office, Minitab, CAD or equivalent) are required

Excellent interpersonal and effective communication skills with internal and external stakeholders ranging from fellow scientists and stakeholders within the company to external parties (customers, vendors etc)

5+ years experience in a high complexity clinical laboratory setting, minimum of 2 years in molecular pathology

Must be able to fulfill the requirements to hold the technical supervisor position in a high complexity molecular pathology laboratory

PhD biological sciences with specialized training and/or appropriate experience in molecular pathology

Minimum of 5 years experience in a clinical laboratory setting

Preferred

Hands-on experience with bioinformatics and bioinformatics tools for sequencing data to enable experimental iteration independent of external support will provide an advantage

Familiarity with more advanced techniques like DOE is an advantage

ASCP certification/NYS CQ preferred

Benefits

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off for vacation, personal, sick and holidays

Multiple other perks and benefits

Company

CooperCompanies

CooperCompanies (Nasdaq: COO) is a leading global medical device company focused on helping people experience life’s beautiful moments through its two business units, CooperVision and CooperSurgical.

Founded in 1958

San Ramon, California, US

10001+ employees