Scientist I/Scientist II, Gene Therapy Analytical Development @ Sarepta: Sarepta Therapeutics is focused on developing first-in-class RNA-based therapeutics to improve and save the lives of people affected by serious and life-threatening rare and infectious diseases. The Company’s diverse pipeline includes its lead program eteplirsen, for Duchenne muscular dystrophy, as well as potential treatments for some of the world’s most lethal infectious diseases. Sarepta aims to build a leading, independent biotech company dedicated to translating its RNA-based science into transformational therapeutics for patients who face significant unmet medical needs. For more information, please visit us at www.sarepta.com.

Scientist I/Scientist II, Gene Therapy Analytical Development @ Sarepta

Tracking Code: 18-305

The Position:

This individual provides bioanalytical test methods development and validation support.  The candidate will also be a member of a team that is involved in developing methods that will be used in process, release and stability testing of AAV based gene therapy products for DMD and related diseases.  The individual will be responsible for characterizing an immortalized animal cell line and developing in-vivo and in-vitro test methods for potency and efficacy of the therapies that will be supporting regulatory filings and clinical comparability.  This position reports to the Senior Director of Analytical Sciences.

You look forward to responsibilities that include:

  • Develop and refine bioanalytical test methods for AAV based gene therapy products intended for clinical applications.
  • The test methods include qPCR, ELISA, SDS-PAGE/Western blot, cell-based potency assays, FACS based separation of cells expressing cell surface markers, to support the manufacture, purification and clinical comparability of AAV products.
  • Interact with AALAC accredited animal care CRO’s to manage in-vivo test methods
  • Develop strategies to stage appropriate validation and transfer of these methods from to Quality Control and manage the lifecycle of these methods.
  • Act as company liaison for method transfer across various CMO/CRO sites.
  • Evaluating CRO/CMO test results and writing summary reports of the results as needed
  • Develop and maintain clear and concise lab records and documentation
  • Author development reports, study protocols, and pre-validation reports
  • Perform other related duties incidental to the work described
  • Develop and manage the Bioanalytical Group within Analytical Sciences

Scientist I/Scientist II, Gene Therapy Analytical Development @ Sarepta

You meet all of the following minimum requirements: 

  • M.S. or Ph.D. degree in Bioanalytical Chemistry, Biology, Biochemistry, Virology or related field with at least 0-3 years relevant experience
  • A strong understanding of Bioanalytical chemistry and a demonstrable grasp of a wide range of technologies qPCR, SDS-PAGE. HPLC, Capillary Electrophoresis, ddPCR, cell based assays, ELISA as applied to gene therapy products is required.
  • Hands-on, development of qPCR, ELISA, Western blot, SDS-PAGE/capillary electrophoresis test methods desired.
  • Working in a cGMP environment and experience in writing regulatory documents would be considered additional qualifications
  • Must have effective written and verbal communication skills
  • Operate as part of a team; assisting fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency

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.

Scientist I/Scientist II, Gene Therapy Analytical Development @ Sarepta

Job Location: Andover, Massachusetts, United States

Position TypeFull-Time/Regular

Apply online

 

Leave a Reply