{"id":1703129,"url":"https://alion.io/job/coopercos-embryologist-scientist","title":"Embryologist Scientist","company":{"id":2859488,"name":"CooperCompanies","domain":"coopercos.com","url":"https://alion.io/company/coopercos","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":80,"open_postings":12,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":14,"computed_at":"2026-10-08T05:49:30Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Sugar Land, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":71000,"max_usd":135000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":861},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-06-08T14:57:42Z","employer_posted_date":"2026-06-08","last_verified_at":"2026-10-09T01:36:03Z","board_verified":true,"closed_at":null,"days_open":122,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":121},"description":"About CooperSurgical\nCooperSurgical 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.\nWork location: Sugar Land, TX (on-site)\nScope:\nThe 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. The scope of this role spans research, assay development, validation, and method transfer, functioning as a critical interface between Research & Development, Quality Control, and Quality Assurance. The position has direct influence on biological risk assessment, regulatory readiness, product lifecycle decisions, and continuous improvement initiatives. 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 performed within this scope directly impacts product quality, regulatory compliance, and patient outcomes in assisted reproduction.\nJob Summary:\nThe Embryologist Scientist is responsible for the design, development, optimization, validation, and scientific troubleshooting of biological assays, including Mouse Embryo Assays (MEA) and sperm function assays, used to support ART product development and quality monitoring. This role conducts hands-on laboratory experimentation, performs statistical and biological data analysis, and leads scientific investigations related to assay performance, media failures, environmental influences, and OOS/OOT events. The scientist develops and validates new methods, establishes positive control systems, and transfers qualified assays into routine Quality Control use, including training and ongoing support.\nThe position collaborates closely with QC, QA, Manufacturing, and external partners, contributing technical expertise to CAPAs, deviations, validations, and continuous improvement initiatives, while advancing innovative bioassay strategies to support current and future ART technologies.\n 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\n\nEstablishment and validation of medical device extraction methods following ISO 10933 methods\n\nImprove assay sensitivity, robustness and reproducibility through endpoint selection, exposure modes, dose-response systems\n\nDevelop and validate positive control systems (e.g., embryotoxic gradients, stress models)\n\nEvaluate emerging technologies and methodologies for embryo culture and reproductive testing\n\nSupport development of next-generation biological safety assays\n\nLead and execute assay validation activities, aligned with IQ/OP/PQ principes where applicable\n\nAuthor validation protocols, risk assessments and final reports in alignment with ISO 17026 and GLP principles\n\nConduct inter-laboratory comparison and method equivalency studies\n\nTransfer validated methods into QC laboratories and provide technical training, ongoing assay support and troubleshooting guidance\n\nLead scientific investigations related to OOS and OOT results (e.g., MEA failures), media performance issues and environmental or system impacts (e.g., incubator performance)\n\nApply structured root-cause analysis tools, including 5 Whys and Fishbone (Ishikawa) analysis\n\nDesign hypothesis-driven experiments to confirm root cause and corrective actions\n\nEnsure compliance with applicable regulatory and quality standards ISO 17025 (preferred) and GLP / GMP principles where applicable\n\nInternal quality systems (CAPA, change control, document control)\n\nAuthor, review, and revise SOPs, work instructions, technical and investigation reports\n\nSupport internal, external, and regulatory audits\n\nEnsure data integrity, traceability, and documentation accuracy\n\nPerform statistical and trend analysis, including ANOVA, variability and reproducibility assessments and assay performance trending\n\nInterpret biological assay data and draw scientifically defensible conclusions\n\nPrepare technical summaries and present findings to R&D, Quality Assurance, Quality Control, Manufacturing and leadership teams\n\nCollaborate with QC laboratories (method transfer and troubleshooting), Manufacturing (process-related investigations), Quality Assurance (CAPA, deviations, validation support), External partners, CROs, and reagent suppliers\n\nSupport product development, lifecycle management, and continuous improvement initiatives\n\nTravel:\nThis is an onsite position with minimal travel requirements (up to 10%).\n Knowledge, Skills and Abilities:\nTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.\nSignificant experience in bioassay research, including experimental design and execution, with a strong focus on embryology.\nExcellent knowledge of bioassay methodologies, instrumentation, and data analysis techniques.\nExcellent organization skill and demonstrated ability to accurately complete detailed work.\nStrong oral and written communication skills and computer literacy.\nStrategic thinking and ability to translate vision into actionable plans.\nKnowledge of relevant regulatory requirements and compliance standards\nAbility to read, analyze, and interpret complex documents. \nAbility to define problems, collect data, establish facts, and draw valid conclusions. \nAbility to complete assignments accurately and with attention to detail.\nAbility to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.\nAbility to analyze, organize and prioritize work under pressure while meeting deadlines.\nAbility to maintain detailed records and observations.\nAbility to process and handle confidential information with discretion.\nAbility to work evenings and weekends as required.\nAbility to work independently and/or in a collaborative environment. \nAbility to work under deadlines with general guidance.\nWork Environment:\nWeekends and holidays may be required.\nWhile performing the duties of this job, the employee is regularly required to stand and occasionally ascend/descend a ladder to perform husbandry tasks.\nFrequently stand, walk, twist, bend, stoop, squat, grasp lightly, use fine manipulation, grasp forcefully, perform desk-based computer task, use telephone, write by hand, lift, carry, push and pull objects over 40 pounds.\nOccasionally sit, kneel, crawl, reach and work above shoulders.\nAbility to bend, squat, kneel, stand, reach above shoulder level, and move on hard surfaces for up to eight hours. \nAbility to work in dusty, dirty, and odorous environment.\nPosition may require repetitive motion.\nSpecific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.\nExposure to animal allergens, anesthetic gases, biohazards, radiation, sharps.\nUse of Personal Protective Equipment (PPE) is required (scrubs, disposable gown, exam gloves, head/beard cover, surgical mask.\nMay require extended or unusual work hours based on research business needs.\nThe noise level in the work environment is usually moderate.\nExperience:\nMin 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.\nSignificant experience in bioassay testing, particularly in routine product release and quality control within embryology and bacterial endotoxin laboratories.\nSufficient computer knowledge of databases.\nMust possess a high level of initiative and ability to work with little supervision.\nBroad knowledge of biology laboratory practices.\nIn-depth technical and scientific knowledge of embryology is desired.\nPrevious experience in laboratory setting is highly desired.\nEducation:\nM.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.\n\nOur Benefits:\nAs 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.\nTo 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.\nWe 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. 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