About this role
Assay Validation Scientist Include but are not Limited to the Following:
The Assay Validation Scientist is primarily responsible for conducting the successful and efficient transfer of technology into the laboratory including method/assay validation execution to meet corporate/client timelines and cost objectives.
Level I – Minimum
Learn new techniques and instrumentationImplement assay validation plans, design, and protocolsOperate, calibrate and maintain all laboratory equipment and instruments according to standard operating procedures to ensure quality resultsKeep accurate documentation of all validation project steps according to Eurofins Viracor regulatory guidelinesCompose and analyze validation data Perform peer review of documentation and dataAssist in writing validation protocols, validation reports, standard operating procedures and study-specific work instructionsParticipates in quality assurance/quality improvement activities. Follows all QC guidelines as stated in the Procedure ManualDisposes of bio-hazardous materials, chemical waste, sharp and other potentially hazardous materials according to PolicyAccurate pipetting and bench-level skills (i.e., pipette standard curves to within accurate limits stated in procedure manual)Other duties as assigned by managementLevel II – Fully meets the responsibilities of Level I plus the following:
Writes standard operating procedures and study-specific work instructions with minimal assistanceWrites validation plans and reports with minimal assistanceAssists on establishing clear timelines per assigned projects and coordinating schedulingProficient in multiple platforms and supporting applicationsAbility to successfully multitask more than one assignment at a given timePrepare data for presentation at scientific meetings or for client presentationsLevel III – Fully meets the responsibilities of Level II plus the following:
Leads design and execution of validation projects with little to no assistance from senior managementAnalyzes and interprets data independentlyIndependently devises/writes validation plans and project reportsObtain advanced knowledge of Viracor Eurofins standard operating procedures, assays, and instrumentationInstructs other scientists and leads their development As appropriate, communicates with clients within project meetings or independently via email or teleconference Basic Minimum Work Requirements:
Level I – Minimum
Minimum of 1 year of experience in method/assay validationAbility to solve problems, prioritize and multi-task in a deadline driven environmentWilling to work with potentially infectious human blood and body fluidsMust possess skills required for aseptic techniquesAnalytical judgment, problem solving skills, accuracy and strong detail orientedDemonstrates a high level of integrity and honesty in performing tests, documenting and maintaining patient, client, employee and laboratory business confidentialityExcellent verbal & written communication skillsHigh level of proficiency with PC based software programLevel II – Fully meets the responsibilities of Level I plus the following:Minimum of 3 years in method/assay validationPossess the required skills to perform the additional level requirements aboveLevel III – Fully meets the responsibilities of Level II plus the following:
Minimum of 5 years in method/assay validationPossess advanced knowledge and troubleshooting capabilityAdvanced communication skills, as demonstrated by successful completion of associate/client presentations or CE coursework in presentations or public speakingPossess regulatory knowledge and scientific judgement sufficient to successfully design and lead projects independentlyAuthorization to work in the United States indefinitely without restriction or sponsorship.Basic Minimum Education Qualifications:
• BS or BA in Biology, Microbiology, Clinical Laboratory Science, Chemistry or a relevant field
Physical Requirements:
Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overheadAbility to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group settingAbility to stand for extended periods of time as necessary in the laboratory (4 or more hours)Ability to lift and move items weighing up to 15 poundsPhysical dexterity sufficient to move body frequently around laboratory equipment and instrumentationAbility to continuously operate a personal computer for extended periods of time (4 or more hours)Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgments and decisionsThe essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Position is full-time working Monday - Friday 10:00am - 6:30pm, with overtime as needed. Candidates currently living within a commutable distance of Lenexa, KS are encouraged to apply.
Excellent full-time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA Clinical Trial Solutions is a Disabled and Veteran Equal Employment Opportunity employer.