Assay Validation Scientist

Eurofins USA Clinical Trial Solutions•Lenexa, KS

2d•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. This role involves learning new techniques and instrumentation, implementing assay validation plans, designing and executing protocols, and operating, calibrating, and maintaining laboratory equipment. Accurate documentation, data analysis, and peer review are essential. The scientist will also assist in writing validation protocols, reports, standard operating procedures, and study-specific work instructions, while participating in quality assurance activities and following all QC guidelines. Disposal of hazardous materials and accurate pipetting are also key responsibilities. Higher levels (Level II and III) involve writing procedures and plans with minimal assistance, leading validation projects, analyzing and interpreting data independently, obtaining advanced knowledge of company procedures, and potentially communicating with clients.

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 programs.
Minimum of 3 years in method/assay validation (Level II).
Possess the required skills to perform the additional level requirements above (Level II).
Minimum of 5 years in method/assay validation (Level III).
Possess advanced knowledge and troubleshooting capability (Level III).
Advanced communication skills, as demonstrated by successful completion of associate/client presentations or CE coursework in presentations or public speaking (Level III).
Possess regulatory knowledge and scientific judgement sufficient to successfully design and lead projects independently (Level III).
Authorization to work in the United States indefinitely without restriction or sponsorship.
BS or BA in Biology, Microbiology, Clinical Laboratory Science, Chemistry or a relevant field.

Nice To Haves

Proficient in multiple platforms and supporting applications (Level II+).
Ability to successfully multitask more than one assignment at a given time (Level II+).

Responsibilities

Conduct successful and efficient transfer of technology into the laboratory.
Execute method/assay validation to meet corporate/client timelines and cost objectives.
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.
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.
Participate in quality assurance/quality improvement activities.
Follow all QC guidelines as stated in the Procedure Manual.
Dispose of bio-hazardous materials, chemical waste, sharp and other potentially hazardous materials according to Policy.
Perform accurate pipetting and bench-level skills.
Write standard operating procedures and study-specific work instructions with minimal assistance (Level II+).
Write validation plans and reports with minimal assistance (Level II+).
Assist on establishing clear timelines per assigned projects and coordinating scheduling (Level II+).
Prepare data for presentation at scientific meetings or for client presentations (Level II+).
Lead design and execution of validation projects with little to no assistance from senior management (Level III).
Analyze and interpret data independently (Level III).
Independently devise/write validation plans and project reports (Level III).
Obtain advanced knowledge of Viracor Eurofins standard operating procedures, assays, and instrumentation (Level III).
Instruct other scientists and lead their development (Level III).
Communicate with clients within project meetings or independently via email or teleconference (Level III).