Duties and Responsibilities :
- Serves as the expert and scientific/technical resource within area of expertise.
- Applies and interprets scientific theories, concepts, techniques, and regulatory requirements in clinical studies.
- Review the validation of new assays and instrumentation, ensuring their scientific relevance.
- Review and approve validation documents and Standard Operating Procedures related to new assays and instrumentation.
- Provides technical training and performs competency assessment for operational staff.
- Ensures the quality performance of all technical services associated within area of expertise.
- Provides consultancy on regulatory requirements in area of expertise and participates to regulatory compliance of all technical services provided within area of expertise.
- Performs complex troubleshooting and assists in leading initiatives to solve challenging scientific problems with assays or instrumentation.
- Provides consultation to scientific and operational staff on technical issues.
- Collaborates with operational leaders to evaluate and assess new technology and new assay capabilities.
- Provides technical/scientific consultation to both internal clients (Sales support, Project Management) and external clients to assist with issues and problem solving.
- Participate in vendor scientific relationships to troubleshoot issues and improve capabilities.
- Participates in client visits, audits and inquiries when needed.
- Interacts with clients and prospective clients to discuss technical/scientific issues, ensure effective communication and maintain relationships.
- Presentations to clients and professional groups.
- Review patients' slides.
Requirements :
- 7 years management experience in a clinical laboratory environment within scientific area of expertise.
- Skilled in performing scientific presentations and preparing scientific publications.
- Proven track record of scientific publications.
- Effective communication skills with technical staff, business development staff, peers and clients.
- Computer literate
