Associate Principal Scientist
As a part of Clinical Trials Scientific Affairs, the Associate Principal Scientist will support testing, method development and validation. The Associate Principal Scientist is required to keep up to date with new methods, applications and regulation while providing technical support at the bench, method validation and/or method improvement. The Associate Principal Scientist will report to the Vice President of Clinical Lab Operations.
STATUS: Full Time
LOCATION: ACM Global Laboratories - Headquarters (160 Elmgrove Park, Rochester, NY)
DEPARTMENT: Clinical Trials
SCHEDULE: Monday - Friday, Days
- Ph.D. in Biomedical Sciences, such as, Chemistry, Biology, Immunology, etc. required
- 3 years of experience in a laboratory environment required.
- 3 years of experience in a clinical laboratory preferred.
- Experience in a regulatory environment, including Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Clinical Laboratory Practice (GCLP) preferred.
- Method & Test Development. Perform clinical trials tests, validations, quality control (QC), maintenance work at the bench, and technical support to laboratory technologists to ensure the clinical laboratory meets the needs of all clients, especially non-FDA approved assays to support Clinical Trial clients. Responsible for assay/panel pre-validation and validation and correlation testing globally. Actively participate in method review and/or improvement.Ensure appropriate technical methods are utilized. Prepare scientific data, including sample stability, method information, reference ranges, etc. to support test menu development. Draft and/or review clinical trials reports, such as validations, correlation’s and/or bioanalytical report
- Quality. Provide scientific and technical support on interpretation of laboratory data as required. Establishing and signing off acceptance of reference ranges. Review and approve validation studies of each test for clinical use. In conjunction with the laboratory manager, periodically review laboratory and quality control/assessment data to ensure accurate and precise results are continually produced, and participate in the ACM Global inter-laboratory correlation and standardization process. . Work with the QA department in writing and reviewing Standard Operating Procedures and relevant documentation as necessary. Participation in all activities that seek to ensure compliance with GCP guidelines and CAP accreditation. Comply with policies for the safe, secure and confidential processing and storage of patient and other laboratory information.
- Client Relations. Review client protocols and prepare proposals and quotations to assist the business development team. Advise as necessary. Liaise with Proposals and Business Development and the VP of clinical operations to advice on methodology, instrumentation and costs for new assays to be introduced into the laboratory to assist in the development of quotations. Provide test analytical information and participate in conference calls and meetings with clinical trials analysts, business development and ACM clients.