Assay Validation Scientist

Assay Validation Scientist

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.

• 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
• Participate in quality assurance/quality improvement activities. Follow all QC guidelines as stated in the Procedure Manual
• Disposal 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

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

• Lead design and execution of validation projects with little to no assistance from senior management
• Analyze and interpret data independently
• Independently devise/write validation plans and project reports
• Obtain advanced knowledge of Viracor Eurofins standard operating procedures, assays, and instrumentation
• Instruct other scientists and lead their development
• As appropriate, communicate with clients within project meetings or independently via email or teleconference

• Minimum of 1 year of experience in method/assay validation
• Ability to solve problems, prioritize and multitask in a deadline‑driven environment
• Willingness 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 orientation
• Demonstrate a high level of integrity and honesty in performing tests, documenting and maintaining patient, client, employee and laboratory business confidentiality
• Excellent verbal and written communication skills
• High level of proficiency with PC‑based software programs

• Minimum of 3 years in method/assay validation
• Possess the required skills to perform the additional level requirements above

• 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.

• BS or BA in Biology, Microbiology, Clinical Laboratory Science, Chemistry or a relevant field

• 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…