This individual will be involved in the development of analytical methods and program management in for PMO/PPMO and Gene therapy programs within Analytical Development. The individual will be responsible for developing validatable LC, CE and MS methods for supporting regulatory filings (50% effort) and Managing programs within and outside Sarepta AD (50% effort). The individual will interact with manufacturing, quality control, preclinical and clinical groups to provide coordination of activities for all programs. This position reports to the Associate Director of Analytical Development.
Primary Responsibilities include:
Develop and refine bioanalytical test methods for protein expression in gene therapy products intended for clinical applications.
The test methods include capillary electrophoresis methods, peptide mapping and HPLC methods to support the manufacture, purification and clinical comparability of AAV products.
Serves as subject matter expert on analytical methods for PMO/PPMO and Gene Therapy products intended for early and late stage clinical trials.
Develop strategies to stage appropriate validation and transfer of these methods from to Quality Control and manage lifecycle of these methods.
Act as company liaison with CMO/CTO to coordinate in method development and method transfer across various CMO/CTO sites.
Evaluating CTO/CMO documentation and 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
Education and Skills Requirements:
Ph.D. degree in Bioanalytical Chemistry, Biology or Biochemistry with at least 3-5 years laboratory operations management and program management experience
A strong understanding of Bioanalytical chemistry and a demonstrable grasp of a wide range of technologies Liquid Chromatography, Capillary electrophoresis, SDS-PAGE, Western Blotting, HPLC, ddPCR as applied to pharmaceutical products is required.
Knowledge of LC/MS, peptide mapping and Analytical ultracentrifugation would be additional qualification
Hands-on, development and validation of two or more of HPLC, Capillay Electrophoresis, ELISA, Western blot, SDS-PAGE/Western Blot test methods desired.
Working in a cGMP environment and experience in writing regulatory documents desired
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
Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion
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.
Andover, Massachusetts, United States