Senior Director, Analytical Development, Separation Science and Protein Chemistry

The Senior Director will oversee the development of HPLC and mass spectrometry-based analytical methods for RNA drug substance and drug product (including in-process, release, and stability testing). Direct and manage mass spectrometry-based protein analysis for AAV-based product lines and ADC (siRNA) programs. Oversee development of purity/impurity characterization methods and excipient analysis.

Represent Analytical Development in high-level internal meetings and coordinate method transfers to internal QC laboratories and external GMP testing sites. Oversee creation of protocols for freeze–thaw studies, accelerated degradation studies, and method qualification/validation in collaboration with the Head of Quality Control (or designee). Support troubleshooting of analytical methods at CROs/CTOs and may facilitate transfer of complex analytical assays into GMP laboratories.

Lead the writing and compilation of regulatory documents to support product development and registration.

Qualifications/Requirements:
- HPLC and Mass Spectrometry trained
- 10+ years’ experience in a regulated environment
- Prior management experience leading a team of >5 members

Reporting/Location:
- Reports to the Vice President of Analytical Sciences
- On-site work at a Sarepta facility in the United States

Application instructions:
- Apply for this position (work authorization in the U.S. required)