Sarepta Therapeutics is seeking a motivated individual with histology and histology related assays. The qualified candidate will provide laboratory support of day-to-day GCLP/GLP testing on muscle/nerve and other tissue types using complex histology methods in accordance with the requirements of approved protocols; maintains records of experiments; assists in analyzing data and prepares laboratory reports. This person may participate in development, GCLP/GLP qualification, and validation of histology related assays to support clinical trials and clinical development decision-making.
Primary Responsibilities Include:
- Performs routine and complex laboratory procedures in histology using frozen section and FFPE techniques.
- Assist in the execution of GCLP/GLP clinical and non-clinical study sample processing, staining and analysis using a variety of assay formats such as Histochemical special stains, Immunofluorescence and Immunohistochemistry.
- Collects and analyzes morphometric data in accordance with appropriate statistical procedures, inclusive of graphs, tables, and photographs of the results for image analysis.
- Assist in sample processing for immunoblotting, and molecular biology studies.
- Processes tissue, blood, urine, and other samples as needed.
- Prepare and maintain reagents and chemical inventory.
- General laboratory maintenance of general and specialized laboratory instrumentation including various types of microscopes and slide scanners.
- Assists in training new employees on technical procedures as assigned in standard methods, practices, procedures, and equipment operations.
- Additional duties include completing general lab tasks, preventive maintenance and quality control. Maintaining a clean working area and adheres to proper safety techniques and procedures. Performs miscellaneous related duties as required.
- Ensure compliance with GCP/GLP guidelines
- Registered HT (ASCP) or Associate's degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution including clinical laboratory training in an approved MLT program with eligibility to sit for the registry exam.
- Ability to execute sample handling and analysis with strict adherence to laboratory methods and SOPs.
- Knowledge of histology techniques (both general and specialized), cryostat-microtomy, microscopy and slide scanners. Experience with muscle and nerve tissue samples preferred.
- Necropsy skill is highly desired.
- Demonstrates the ability to communicate clearly across multiple parties, problem solve complex issues, and plan and develop new procedures or policies with initiative to complete all assignments.
- Desire to work in a high-functioning, collaborative team.
- Experience with computer productivity software (i.e. Word, Excel, etc.)
- Image analysis skill is preferred.
- Excellent written and verbal communication skills
- Desire to work in a dynamic, fast-paced team environment and to make a difference in the lives of people through our innovative medicines.
- Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Patients First, Action, Unconventional Thinking, Talent, and Integrity.