Description
This position will be within the Safety Biomarker group primarily involved in routine clinical pathology (hematology, urinalysis, clinical chemistry) analysis and study coordination to include laboratory scheduling through report generation.
The primary responsibility of this group is to provide routine clinical pathology and investigative biomarker support for compounds in discovery/pre-clinical development to support both efficacy and safety evaluation of drug candidates. Routine clinical pathology analysis involves hematology, clinical chemistry, urinalysis, and sample processing. The routine clinical pathology platforms currently employed in this lab include Siemens Advia hematology, urine and chemistry analyzers along with the Sysmex hematology analyzer. Investigative biomarker capabilities include flow cytometry, multiplex and immuno-based platforms.
Major Responsibilities:
- Provide logistical support for clinical pathology under the direction of senior laboratory scientists. Logistical support will include: sample coordination with discovery/in vivo toxicology group, study initiation in the LIMS system, sample processing, shipping and coordination with other sites to ensure sample integrity, accuracy and timely data reporting.
- Provide consultation for study sample analysis support and perform in-house routine clinical pathology (hematology, clinical chemistry) analyses.
- Assist in equipment/assay validations to support SOP generation and validation documents.
- Participate in team meetings to stay informed on decisions about relevant clinical pathology assays and sample volumes.
- Effectively communicate clinical pathology and biomarker data to the study directors, project team leads and biomarker team leads, and function as part of a collaborative multidisciplinary group.
CANDIDATES WITH PREVIOUS MID-LEVEL EXPERIENCE AS A MEDICAL TECHNOLOGIST IN A HOSPITAL SETTING WOULD BE IDEAL CANDIDATES.
REQUIRED:
- BS and 5 years related experience.
- Experience with Laboratory Information Management Systems (LIMS)
- Direct laboratory experience in automated clinical chemistry and hematology platforms, experience with LIMS, good understanding of assay validation principles, standard operating procedures and excellent oral and written communication skills and ability to multitask.
- Entry level MS.
- ASCP/MLT/CLS certification
- Advanced knowledge in hematology and chemistry platforms, multispecies experience including immunoassay and/or flow cytometry technology.
- Experience working on collaborative research projects within a Matrix organization.
- Pharmaceutical or contract research lab experience, specifically in biomarker/clinical pathology.
- Highly motivated and enthusiastic scientist with proven record of independent analytical thinking and collaborations.
- Ability to relish change, energize others and passion about work.