About This Role
This role involves providing expert guidance and support in genetic toxicology, contributing to field research, and ensuring the scientific validity of studies for the FDA. It suits a professional with a strong background in scientific research and regulatory operations.
Responsibilities
- Provide input on field research needs, assist in literature searches on research topics, and guide critical thinking and troubleshooting during the actual research period as necessary
- Provide technical guidance/troubleshooting advice to researchers, ensuring scientific validity and that research aligns with current Agency needs
- Provide guidance on appropriate experimental design to satisfy established acceptance criteria for intended purpose (e.g., statistical analysis, validation/verification studies)
- Guide researchers and review research proposals, grant proposals, abstracts, presentations, and publications for quality and scientific validity
- Provide, when required, technical advice to laboratory analysts engaged in establishment inspections, and when required investigators and compliance officers regarding laboratory inspectional and investigational findings for selected case evidence
- Provide, when consulted, opinion in the interpretation of complex scientific data generated and submitted by regulated industry in support of discrepant data investigations or to identify degradation products and unknowns
- Co-author papers and presentations where appropriate and when contributions meet relevant authorship guidelines
- Identify needs for innovative technology, major instrumentation, and assist in development of new methods and experimental design
- Provide Supervisory/Leadership guidance; FD&C Act and related laws & regulations governing FDA regulated products
- Advise management on scientific issues as they relate to the regulatory operations of the unit (especially with procedures which are not used on a day-to-day basis)
- Share extensive knowledge and experience in branch operational procedures (which may be written into Quality Management System (QMS) Standard Operating Procedures (SOPs))
Requirements
- College degree required, Masters or PhD preferred
- 5+ years of recent relevant experience
Benefits
- Paid holidays
- Paid time off including sick and vacation leave
- Medical, dental, and vision insurance
- Flexible spending accounts
- Short and long term disability
- Company paid life insurance
- 401(k) with a company match and discretionary profit sharing
- Tuition reimbursement
About the Company
TekPro Support Services (TSS) is a professional solutions firm supporting several military installations and federal agencies across the nation with Financial, Administrative, Technical, and Scientific capabilities. TSS is currently contributing to an ongoing mission with the FDA.