Assay Validation Scientist

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 instrumentation
• Implement assay validation plans, design, and protocols
• Operate, calibrate and maintain all laboratory equipment and instruments according to standard operating procedures to ensure quality results
• Keep accurate documentation of all validation project steps according to Eurofins Viracor regulatory guidelines
• Compose and analyze validation data 
• Perform peer review of documentation and data
• Assist in writing validation protocols, validation reports, standard operating procedures and study-specific work instructions
• Participates in quality assurance/quality improvement activities. Follows all QC guidelines as stated in the Procedure Manual
• Disposes of bio-hazardous materials, chemical waste, sharp and other potentially hazardous materials according to Policy
• Accurate pipetting and bench-level skills (i.e., pipette standard curves to within accurate limits stated in procedure manual)
• Other duties as assigned by management

Level II – Fully meets the responsibilities of Level I plus the following:

• Writes standard operating procedures and study-specific work instructions with minimal assistance
• Writes validation plans and reports with minimal assistance
• Assists on establishing clear timelines per assigned projects and coordinating scheduling
• Proficient in multiple platforms and supporting applications
• Ability to successfully multitask more than one assignment at a given time
• Prepare data for presentation at scientific meetings or for client presentations

Level 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 management
• Analyzes and interprets data independently
• Independently devises/writes validation plans and project reports
• Obtain advanced knowledge of Viracor Eurofins standard operating procedures, assays, and instrumentation
• Instructs 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 validation
  • Ability to solve problems, prioritize and multi-task in a deadline driven environment
  • Willing to work with potentially infectious human blood and body fluids
  • Must possess skills required for aseptic techniques
  • Analytical judgment, problem solving skills, accuracy and strong detail oriented
  • Demonstrates a high level of integrity and honesty in performing tests, documenting and maintaining patient, client, employee and laboratory business confidentiality
  • Excellent verbal & written communication skills
  • High level of proficiency with PC based software program
• Level II – Fully meets the responsibilities of Level I plus the following:
  • Minimum of 3 years in method/assay validation
  • Possess the required skills to perform the additional level requirements above

• Level III – Fully meets the responsibilities of Level II plus the following:

  • Minimum of 5 years in method/assay validation
  • Possess advanced knowledge and troubleshooting capability
  • Advanced communication skills, as demonstrated by successful completion of associate/client presentations or CE coursework in presentations or public speaking
  • Possess regulatory knowledge and scientific judgement sufficient to successfully design and lead projects independently
• Authorization 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 overhead
• Ability 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 setting
• Ability 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 pounds
• Physical dexterity sufficient to move body frequently around laboratory equipment and instrumentation
• Ability 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 decisions

The 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 options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA Clinical Trial Solutions is a Disabled and Veteran Equal Employment Opportunity employer.