Embryologist Scientist

CooperCompanies•Sugar Land, TX

3d•Onsite

About The Position

CooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting women, babies, and families. As a division of CooperCompanies, we aim to enable patients to experience life's beautiful moments. Our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care. We offer over 600 clinically relevant medical devices, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. 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. This role spans research, assay development, validation, and method transfer, acting as a critical interface between Research & Development, Quality Control, and Quality Assurance. The position influences biological risk assessment, regulatory readiness, product lifecycle decisions, and continuous improvement. Operating within a regulated laboratory environment, the role supports compliance with ISO 17025, GLP, and applicable GMP principles, and plays a key role in scientific investigations, OOS resolution, assay robustness, and next-generation bioassay development. The work directly impacts product quality, regulatory compliance, and patient outcomes in assisted reproduction.

Requirements

Min 7+ years related experience and/or training in embryology or reproductive biology laboratory, bioassay development and execution. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Significant experience in bioassay testing, particularly in routine product release and quality control within embryology and bacterial endotoxin laboratories.
Sufficient computer knowledge of databases.
Must possess a high level of initiative and ability to work with little supervision.
Broad knowledge of biology laboratory practices.
M.S or Ph.D. or equivalent in Embryology, Reproductive Biology, Animal Science, Biochemistry, Biotechnology, or a field.
The candidate should have a strong academic background in embryology, reproductive sciences or related discipline.
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.

Nice To Haves

In-depth technical and scientific knowledge of embryology is desired.
Previous experience in laboratory setting is highly desired.

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
Establishment and validation of medical device extraction methods following ISO 10933 methods
Improve assay sensitivity, robustness and reproducibility through endpoint selection, exposure modes, dose-response systems
Develop and validate positive control systems (e.g., embryotoxic gradients, stress models)
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 principes 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)
Author, review, and revise SOPs, work instructions, technical and investigation reports
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