Senior Associate Scientist, IVD Test Dev

About this job

• 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

• Bachelor's degree in biology, Biochemistry, Molecular Biology, or a related field with2-4 years of relevant experience.
• Master's degree with1-2years of experience
• Industry experiencepreferable

• 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

• 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 and fluorescent lighting

• Full-time on-site position; this is not a remote position
• May require infrequent travel
• Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples)
• 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
• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.

Compensation details: 0 Yearly Salary

PId6bd8e5-