Job Description

About CooperSurgical

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com

The Lead Scientist, Genomics is responsible for ensuring the accuracy, integrity, and regulatory compliance of all genomic test data prior to clinical reporting. This role serves as a critical quality checkpoint in the laboratory workflow, reviewing raw and processed genomic data, analytical results, and supporting documentation to verify adherence to scientific, regulatory, and quality standards.

Working cross-functionally with laboratory operations, R&D, and quality assurance, the Lead Scientist will work to identify discrepancies, resolve issues, and ensure that finalized results meet the laboratory’s standards for reliability, regulatory compliance, and patient safety. The Data Reviewer also plays an essential role in ensuring that genomic test results are scientifically valid, clinically relevant, and delivered with precision.

• Perform detailed end-to-end review of analytical, bioinformatics, and QC data to ensure accuracy, completeness, and compliance with SOPs, regulatory standards, and laboratory accreditation requirements.

• Verify quality control (QC) metrics, instrument outputs, and bioinformatics analyses prior to result release.

• Ensure all data, laboratory notes, and electronic records are complete, accurate, and traceable.

• Maintain thorough documentation of reviews, including discrepancies, corrective actions, and approvals.

• Identify inconsistencies, errors, or anomalies in data sets.

• Support compliance with Good Documentation Practices (GDP) and electronic record regulations (e.g., 21 CFR Part 11).

• Collaborate with laboratory staff, bioinformaticians, and quality assurance to investigate and resolve discrepancies.

• Ensure all data review activities adhere to CLIA, CAP, ISO 15189, and internal QMS requirements.

• Support audits and inspections by providing accurate documentation and data review records.

• Contribute to continuous improvement initiatives related to data integrity and laboratory compliance.

• Foster a culture of accountability, collaboration, and continuous learning.

Travel: This role is site/home based, though domestic/regional travel may be required (<5%).

Work Environment:

• This is an office/home office based position

• Extensive use of computers, multiple monitors, LIMS, bioinformatics software, dashboards, and reporting tools to review and verify genomic data.

• Occasional after-hours or weekend support may be required to support operational demands.

• Prolonged periods of sitting and working at computer workstations.

• Light lifting (<20 lbs.) for documents, binders, or workstation equipment.

• 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.

• 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.
• 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).
• Working knowledge of CLIA, CAP, ISO 15189, and GxP principles for data integrity, traceability, and operational documentation.
• Knowledge of data integrity principles, SOP compliance, and documentation best practices.
• High attention to detail with strong analytical and critical-thinking skills for identifying discrepancies in large, complex data sets.
• Comfortable with managing change in a dynamic lab environment with shifting priorities.
• Ability to manage multiple initiatives, prioritize competing demands, and allocate resources for maximum impact.
• Ability to work independently with a high degree of accuracy, accountability, and consistency.
• Ability to remain focused when reviewing complex datasets and repetitive tasks.

Experience and Education:

• 7+ years experience in a high complexity clinical laboratory setting, minimum of 2 years in molecular pathology.
• Hands-on familiarity with next-generation sequencing (NGS) data, PCR/qPCR, or other genomic technologies. Familiarity with PGT-M strongly preferred

• Bachelor’s degree in the Biological Sciences. Master’s or higher degree preferred

Our Benefits:

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $130,000.00 - $140,000.00 annually. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.