Research Associate II

Sarepta Therapeutics is seeking a highly motivated individual with expertise in bioanalytical method development using molecular and histological assays. The Research Associate II, Translational Biology will support the day-to-day testing of biological samples from clinical and pre-clinical trials in accordance with the requirements of approved protocols and regulatory guidance. The Research Associate will have strong expertise in molecular and histological assays and utilize this experience to perform early and late stage assay development, qualification and validation, assay execution. The Research Associate will support data recording, summarization, and reporting. The Research Associate will contribute to assay development, validation and clinical and pre-clinical sample testing to support ongoing clinical trials. Additional responsibilities include contributing to laboratory compliance and inspection readiness activities and drafting methods, SOPs, protocols and technical reports.
Primary Responsibilities Include

• Conduct sample analysis in accordance with GLP/GCLP standards using a variety of assay formats including ddPCR, western blot, SimpleWestern, immunohistochemistry/immunofluorescence, and ELISA.
• Responsible for managing project deliverables and timelines. Will coordinate activities and timelines in close collaboration with the laboratory team(s), Clinical Operations, Data Management, Biostatistics, and CROs.
• Support the development, validation and implementation of bioanalytical methods for new and/or improved clinical biomarker assays.
• Support the preparation of written test protocols and study reports and support data transfer and analysis in collaboration with intramural and extramural teams.
• Responsible for sample logistics and data management across multiple clinical and non-clinical trials.
• Support digital image acquisition, morphometric image analysis and interpretation.
• Support the onboarding and qualification of new equipment and software.
• Assist in training new employees on technical procedures as assigned in standard methods, practices, procedures, and equipment operations.
• Completing general lab tasks, preventive maintenance and quality control, maintain a clean working area and adhere to proper safety techniques and procedures while ensuring compliance with GCP/GCLP guidelines. Assist in maintaining laboratory compliance and inspection readiness.
  

Desired Education And Skills

• Bachelor’s degree in a chemical, physical or biological science with 3+ years of experience in healthcare, biotech/pharmaceutical industry or equivalent.
• Ability to execute sample handling and analysis with strict adherence to laboratory methods, and SOPs using Good Documentation Practices (GDP)
• Working knowledge of biomedical research methodologies including PCR, Western Blot and ELISA.
• Knowledge of histology and immunohistochemical techniques
• Proven scientific leadership when working with collaborative, multi-functional teams and troubleshooting complex laboratory processes.
• Desire to work in a dynamic, fast-paced, high functioning and collaborative team environment and to make a difference in the lives of people through innovative medicines
• Ability to work extended hours as needed, including but not limited to weekend and holiday coverage, occasionally on short notice
• Experience and/or willingness to be trained in necropsy procedures
  

This position requires work on site at one of Sarepta’s facilities in the United States.
The targeted salary range for this position is $68,000 - $85,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.