Unknown Company
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
- Participate in quality assurance/quality improvement activities. Follow 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
- Write standard operating procedures and study-specific work instructions with minimal assistance
- Write validation plans and reports with minimal assistance
- Assist on establishing clear timelines per assigned projects and coordinate 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
- 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