Scientist II Translational Biology
Scientist II Translational Biology
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Job Description
Why Sarepta Why Now
The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limbgirdle muscular dystrophies (LGMDs) and we currently have more than 40 programs in various stages of development in gene therapy RNA and gene editing. In 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and worklife resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits see our website: Importance of the Role
Sarepta Therapeutics is seeking a motivated facilitydependent scientist with expertise in ligandbinding and PCRbased assay development validation and reporting with a specific emphasis in nonclinical GLP studies and outcomes. The qualified candidate will provide scientific oversight into the development strategies and validation studies in alignment with current regulatory guidance for Bioanalytical Method Validation. This position will lead daytoday GCP/GLP analysis on nonclinical and clinical samples ensuring the requirements of approved protocols methods and procedures are upheld. This position will prepare relevant sections of testing study/contributing scientist reports and regulatory documents. The position includes integration of data across platforms study metadata and study results for presentation in meetings reports and regulatory documents. Additional duties include contributing to laboratory compliance and inspection readiness activities and drafting methods SOPs protocols technical reports and regulatory document preparation. This role may serve as Study Director for Method Validation and Clinical Testing studies or Contributing Scientist for GLP studies. This position will be a key technical point of contact for Research Operations Clinical Operations Data Management Biostatistics and vendors for data transfer and analysis needs.The Opportunity to Make a Difference
Conduct GCP/GLP nonclinical and clinical study sample analysis under the direction of project management teams using a variety of assay formats such as PCR IP Western blot IHC and NGS while ensuring compliance with associated protocols methods and procedures.
Work closely with Quality Control and Quality Assurance to ensure compliance with GDP GCP GLP and appropriate regulatory guidelines including writing and reviewing SOPs technical reports and publications and maintaining compliant laboratory records.
Contribute to laboratory compliance inspection readiness activities and regulatory agency related written communications as an SME for this function. Laboratory compliance includes but is not limited to being up to date with the required trainings and following the laboratory cleaning and maintenance SOP.
Take a lead role in the development and validation of fitforpurpose bioanalytical methods for various clinical stage programs.
Coordinate activities and timelines through close collaboration with project management teams research teams as well as crossfunctional Translational Biology colleagues. This includes maintaining sample testing trackers summary statistics for reports and testing metrics.
Train team members on assays sample processing and reporting workflows.
Organize and track complex information prioritize accordingly and quickly adjust to shifting priorities and demanding timelines to support the overall goals of the department.
Work extended hours as needed including but not limited to weekend and holiday coverage occasionally on short notice.
Additional responsibilities as assigned.
More about You
- Knowledge of neuromuscular biology gene and siRNA therapies especially in the context of rare genetic disease.
- Experience with molecular biology assay development including but not limited to qPCR RTPCR ddPCR ELISA and Western Blot.
- Demonstrated handson experience with PK assays for nonclinical and clinical studies under the GxP umbrella
- Understanding of drug development nonclinical safety studies and experimental design within GLP research environment.
- Proven scientific leadership when working with collaborative multifunctional teams.
- Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.
- A strong record of demonstrating critical thinking decision making and creative problemsolving skills.
- Experience with project and data management software (MS Project WorkFront PowerBI etc. is a plus.
What Now
Were always looking for solutionoriented critical thinkers.
So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.
Employment Type
Full-Time
