Assay Validation Scientist

Eurofins•Lenexa, KS

9h•Onsite

About The Position

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

Requirements

Minimum of 1 year of experience in method/assay validation (Level I)
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
Minimum of 3 years in method/assay validation (Level II)
Possess the required skills to perform the additional level requirements above
Minimum of 5 years in method/assay validation (Level III)
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.

Responsibilities

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)
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
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