Senior Associate Scientist, IVD Test Dev at Cleveland Diagnostics

Cleveland, Ohio, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Jun, 26

Salary

90000.0

Posted On

12 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Assay Optimization, Assay Verification, Assay Validation, Regulatory Submissions, PMA, 510(k), IVDR, Laboratory Experiments, Statistical Analyses, Data Analysis, Documentation, Troubleshooting, Reagent Preparation, Biosafety Procedures, Immunochemistry Analyzers, Design Control

Industry

Biotechnology Research

Description

We are seeking a Senior Associate Scientist-IVD Test Development to support in-vitro diagnostic assay development and validation activities within a regulated environment operating under design control. The successful candidate will execute laboratory experiments and contribute to assay optimization, verification, and validation studies in support of regulatory submissions including PMA, 510(k), and IVDR. Title: Senior Associate Scientist, IVD Test Development Location: On-site, Cleveland, Ohio Reports to: Sr Director, IVD Test Development Job Description: The Senior Associate Scientist will support in-vitro diagnostic assay development and validation activities within a regulated environment operating under design control. The successful candidate will execute laboratory experiments and contribute to assay optimization, verification, and validation studies in support of regulatory submissions including PMA, 510(k), and IVDR. This role requires strong hands-on technical skills, attention to detail, and the ability to follow established protocols while contributing to experimental planning and troubleshooting under the guidance of a supervisor. The Senior Associate Scientist will perform routine and non-routine laboratory procedures, analyze and summarize data, maintain accurate documentation in accordance with quality system requirements, and assist in preparing technical reports and study documentation. In addition to laboratory execution, this position will support lab organization, equipment maintenance, reagent preparation, and continuous improvement initiatives to ensure efficient study execution. The role involves handling human biological specimens, including blood, plasma, urine, and other bodily fluids, in compliance with all safety regulations and company policies. Essential Duties and Responsibilities * In collaboration with a supervisor, design and plan laboratory experiments with clearly defined objectives and success criteria. * Independently execute laboratory experiments supporting assay development, optimization, verification, and validation in accordance with approved protocols and design control requirements. * Provide technical input toward refinement of new diagnostic assays and improvements to existing assay workflows. * Independently apply basic to intermediate statistical analyses to study results and ensure data accuracy and integrity. * Prepare data summaries, figures, tables, and preliminary interpretations for internal technical review. * Maintain complete, accurate, and GDP/QMS-compliant experimental records and documentation. * Perform routine troubleshooting of assays, instrumentation, and laboratory workflows; escalate complex issues appropriately. * Prepare reagents, solutions, and study materials while ensuring traceability and proper documentation. * Demonstrate accountability for assigned workstreams, meeting study timelines, documentation standards, and data quality expectations. * Coordinate with vendors and internal teams to procure laboratory supplies and maintain operational readiness. * Actively participate in technical discussions, team meetings, and cross-functional reviews. * Ensure compliance with all safety policies, biosafety procedures, laboratory standards, and company requirements. * Other duties as assigned Qualifications/Requirements * Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 2-4 years of relevant experience. * Master’s degree with 1-2 years of experience * Industry experience preferable Technical Skills: * Hands-on experience with standard laboratory techniques such as pipetting, reagent preparation, and handling. (Experience with automated immunochemistry analyzers preferred). * Ability to follow standard protocols and troubleshoot routine lab tasks * Experience with data analysis and documentation best practices * Familiarity working in an FDA or ISO-regulated environment is a plus * Proficient with computer skills and with Microsoft Office applications Physical Requirements/Working Conditions/Equipment Used: * Fine motor skills and manual dexterity to handle specimens and lab equipment required to process specimens, troubleshoot and repair instrumentation. * Visual acuity to examine specimens and reagents * Offices reachable by elevator but should be able to climb stairs if needed * Light lifting may be required (up to 25 pounds) * May be required to stand for long periods of time * Ability to operate a computer and other technology related lab equipment through course of day * Ability to work in an environment with exposure to hazardous chemicals and biohazards * Ability to comply with all appropriate job PPE requirements * General office and HVAC noise Other Requirements * Full-time on-site position; this is not a remote position * This position is classified as exempt and may require work in excess of 8 hours per day and/or 40 hours per week as business needs dictate * May require infrequent travel * Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples) ------------------------------------------------------ Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee’s well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics. Cleveland Diagnostics offers an extremely robust benefits package which includes: * 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage * 100% Employer-paid Dental & Vision for entire family * No cost for employee coverage for Group Term Life, Short- & Long-Term Disability * 4% retirement contribution Employer match * Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs) * Paid Family Leave Program * Generous PTO plan & holiday program * Flexible work schedule & lucrative employee referral program * Salary range may vary by work state/geographical region/territory * Easy to get to office location with newly built-out office space * Free coffee, snacks and other goodies all day long Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company’s status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.

Responsibilities

The Senior Associate Scientist will execute laboratory experiments, contribute to assay optimization, verification, and validation studies for in-vitro diagnostic assays within a regulated environment. This includes designing experiments, performing statistical analyses, maintaining accurate documentation, and troubleshooting laboratory procedures.