Job Description

Work location: Sugar Land, TX (on-site)

Scope:

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. 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.

Job Summary:

The 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.

The 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.

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

Travel:

This is an onsite position with minimal travel requirements (up to 10%).

Qualifications

Knowledge, Skills and Abilities:

To 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.

• 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.

Work Environment:

1. Weekends and holidays may be required.
2. While performing the duties of this job, the employee is regularly required to stand and occasionally ascend/descend a ladder to perform husbandry tasks.
3. Frequently 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.
4. Occasionally sit, kneel, crawl, reach and work above shoulders.
5. Ability to bend, squat, kneel, stand, reach above shoulder level, and move on hard surfaces for up to eight hours.
6. Ability to work in dusty, dirty, and odorous environment.
7. Position may require repetitive motion.
8. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.
9. Exposure to animal allergens, anesthetic gases, biohazards, radiation, sharps.
10. Use of Personal Protective Equipment (PPE) is required (scrubs, disposable gown, exam gloves, head/beard cover, surgical mask.
11. May require extended or unusual work hours based on research business needs.
12. The noise level in the work environment is usually moderate.

Experience:

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

Education:

• 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.

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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.