Embryologist Scientist

About the role

The Embryologist Scientist serves as a scientific subject matter expert responsible for the biological evaluation and advancement of bioassay systems used to assess the safety, efficacy, and performance of assisted reproductive technology (ART) media, consumables, and devices.

Responsibilities

• Conduct a variety of cell-based bioassays (MEA, Sperm motility and survivability assays and Bacterial Endotoxin Test) for research and root cause analysis testing for products utilized in human assisted reproductive laboratories
• Establish and validate medical device extraction methods following ISO 10933 methods
• Improve assay sensitivity, robustness and reproducibility through endpoint selection, exposure modes, dose-response systems
• Evaluate emerging technologies and methodologies for embryo culture and reproductive testing
• Support development of next-generation biological safety assays
• Lead and execute assay validation activities, aligned with IQ/OP/PQ principles where applicable
• Author validation protocols, risk assessments and final reports in alignment with ISO 17026 and GLP principles
• Conduct inter-laboratory comparison and method equivalency studies
• Transfer validated methods into QC laboratories and provide technical training, ongoing assay support and troubleshooting guidance
• Lead scientific investigations related to OOS and OOT results (e.g., MEA failures), media performance issues and environmental or system impacts (e.g., incubator performance)
• Apply structured root-cause analysis tools, including 5 Whys and Fishbone (Ishikawa) analysis
• Design hypothesis-driven experiments to confirm root cause and corrective actions
• Ensure compliance with applicable regulatory and quality standards ISO 17025 (preferred) and GLP / GMP principles where applicable
• Internal quality systems (CAPA, change control, document control)
• Support internal, external, and regulatory audits
• Ensure data integrity, traceability, and documentation accuracy
• Perform statistical and trend analysis, including ANOVA, variability and reproducibility assessments and assay performance trending
• Interpret biological assay data and draw scientifically defensible conclusions
• Prepare technical summaries and present findings to R&D, Quality Assurance, Quality Control, Manufacturing and leadership teams
• Collaborate with QC laboratories (method transfer and troubleshooting), Manufacturing (process-related investigations), Quality Assurance (CAPA, deviations, validation support), External partners, CROs, and reagent suppliers
• Support product development, lifecycle management, and continuous improvement initiatives

Qualifications

• Significant experience in bioassay research, including experimental design and execution, with a strong focus on embryology
• Excellent knowledge of bioassay methodologies, instrumentation, and data analysis techniques
• Excellent organization skill and demonstrated ability to accurately complete detailed work
• Strong oral and written communication skills and computer literacy
• Strategic thinking and ability to translate vision into actionable plans
• Knowledge of relevant regulatory requirements and compliance standards
• Ability to read, analyze, and interpret complex documents
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to complete assignments accurately and with attention to detail
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• Ability to analyze, organize and prioritize work under pressure while meeting deadlines
• Ability to maintain detailed records and observations
• Ability to process and handle confidential information with discretion
• Ability to work evenings and weekends as required
• Ability to work independently and/or in a collaborative environment
• Ability to work under deadlines with general guidance

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.