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.
- 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.
Travel: This role is site based, though domestic/regional travel may be required (<5%)
Work Environment:
- Divided between office and clinical laboratory work environment.
- Position may at times require the employee to work in areas with bloodborne pathogens or where hazardous materials and/or infectious diseases are present.
- At times it will entail prolonged sitting in front of a computer.
- Willingness to adjust work schedule to meet the demands of the company including occasional non-business hours, weekend and/or holiday work
Qualifications, Knowledge, Skills and Abilities:
- 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.
- Hands-on experience with bioinformatics and bioinformatics tools for sequencing data to enable experimental iteration independent of external support will provide an advantage.
- Experience in process, method, or assay development and optimization with thorough understanding of verification and validation methods is required. Familiarity with more advanced techniques like DOE is an advantage.
- 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).
Experience:
- 5+ years experience in a high complexity clinical laboratory setting, minimum of 2 years in molecular pathology.
Education:
- 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.
- ASCP certification/NYS CQ preferred.
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. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at talent.acquisition@coopersurgical.com
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $135,000 - $180,000. 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.
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