We are seeking a Senior Scientist for our Clinical Microbiology Lab in the Indianapolis, IN Lab. The Senior Scientist will be responsible for internal and external technical consultation, method selection and validation and, as appropriate, method implementation, regulatory compliance and production.
Duties will include the following:
- Responsible for consultation with sponsor representatives on testing required to meet their scientific objectives and subsequent translation of protocol requirements into validated laboratory operating procedures and implementation of those procedures.
- Responsible for maintaining areas/activities in inspection ready conditions.
- Guide the development, validation and implementation of new assays. Provide input for new test validation commitments. Establish and keep validation commitment dates.
- Responsible, as assigned, for direct oral and written communication with customers concerning on‑going testing and testing feasibility.
- Required to participate in sponsor visits/audits.
- Required to present lectures to Covance personnel as assigned.
- Required to rotate weekend lab coverage as assigned.
- Required to travel to sponsors for technical consultation as requested.
- Required to extract and analyze data from the clinical trials database.
- Responsible for ensuring that all procedures/processes meet CLIA/CAP/New York State requirements and adhere to all regulatory requirements to include CLIA, CAP, New York State, OSHA, NRC and applicable GLPs
- Required to write procedures as necessary in areas of responsibility according to Covance, CLSI & EUCAST standards as directed.
- Required to monitor and/or respond to internal reports (including responses to QA, Z and R reports, proficiency test responses and external audit findings) are completed within acceptable time frames as requested.
- Required to serve on committees such as, Laboratory Safety Committee, and other associated laboratory focused activities and accept associated assignments.
- Responsible for preparing a monthly report of activities for the Global Director.
- Maintain New York State Certificate of Qualification as required.
- Required to manage testing processes to meet customer requirements.
- Provides technical guidance for all departmental issues.
- Carry out other duties as assigned.