Sarepta Therapeutics is seeking a motivated individual with necropsy and histology related experience. The Lead Research Associate will provide critical laboratory management for all research teams through preclinical animal tissue and sample collection work at the Ohio Genetic Therapies Center of Excellence. The candidate will lead the necropsy function, coordinating necropsy with vivarium teams and study directors as needed. The candidate will lead and assist in the coordination of effort across teams and facilitate efficient high quality sample collection and processing. This role requires laboratory expertise/training in small and large animal handling and specialized necropsy techniques. The qualified candidate will provide laboratory support of day-to-day GLPs (Good Laboratory Practices) testing on muscle, nerve and other types of tissue using complex prosecting and histology methods in accordance with the requirements of approved protocols and SOPs (standard operating procedures); maintains records of activities and experiments; completes data entry using validated data entry computer systems; assists in analyzing data and preparing laboratory reports. This person may participate in development, GLP qualification and validation of necropsy and histology related assays to support clinical development and clinical trials.
Primary Responsibilities Include:
Build, manage and train a team of necropsy prosectors for execution of non-clinical necropsies to support the Gene Therapy, Gene Editing, and RNA programs.
Serve as a subject matter expert on tissue collection practices and participate in internal research team discussions regarding study design and implementation.
Develop, design and implement new procedures within the necropsy team.
Assist in the development of study-specific forms and necropsy schematics.
Performs protocol specific necropsy evaluations of laboratory animals, including but not limited to sample container preparation, harvesting, and weighing of tissues and accurate and timely record keeping.
Performs a variety of tissue preservation techniques including liquid nitrogen immersion, fixation, and perfusion procedures.
Performs tissue trimming according to study protocols.
Coordinates with and manage necropsies with cross-functional department leads including but not limited to vivarium staff, vivarium operations, study directors and pathologists as needed. Assists in ordering supplies related to necropsy and histology activities.
Lead optimization or validation efforts for necropsy equipment as needed.
Manage communications and build relationships CROs and external collaborators with large animal models.
Train and mentor research staff on necropsy procedures.
A strong record of demonstrating critical thinking and creative problem-solving skills.
Flexibility and adaptability to additional projects and responsibilities as assigned to support the overall goals of the department.
Desired Education and Skills:
BS degree in scientific discipline with 5+ years of experience, or MS degree in scientific discipline with 3-5 years of laboratory experience in the healthcare, biotech/pharmaceutical industry or equivalent.
Demonstrated experience managing implementation of research studies under GCP/GLP compliance.
Comfortability with electronic and paper databases, including but not limited to ELN, LIMS, animal tracking and necropsy software.
Previous leadership experience.
Ability of execute sample handling and analysis with strict adherence to laboratory methods and SOPs.
Experience in muscle and nerve tissue handling preferred.
Experience in SOP and method drafting, report generation and knowledge of computerized data entry platforms.
Ensures work is performed to technical expectations and in compliance with GLPs.
Highly organized and detail oriented. Able to participate in multiple studies at a time.
Desire to work in a dynamic, collaborative, fast-paced team environment and to make a difference in the lives of people through innovative medicines.
Proven ability to successfully manage projects and timelines, organize/track complex information, prioritize accordingly, and the ability to quickly adjust to shifting priorities and demanding timelines when necessary.
Ability to work extended hours as needed, including but not limited to weekend and holiday coverage, occasionally on short notice.
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This position requires work on site at one of Sarepta's facilities in the United States.
The targeted salary range for this position is $83,600 - $104,500 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.
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