Senior Director, Analytical Development, Separation Science and Protein Chemistry
Sarepta Therapeutics
June 26, 2026
On-site
Bedford, MA
Operations
The Senior Director will oversee the development of HPLC and mass spectrometry–based analytical methods for RNA (PMO and siRNA) drug substance and drug product (including in-process, release, and stability testing). They will direct mass spectrometry–based protein analysis for the AAV product line and ADC (siRNA) programs, and oversee purity/impurity characterization and excipient analysis.
Responsibilities:
- Represent Analytical Development in high-level internal meetings.
- 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 (with QC leadership/designee).
- Support troubleshooting at CROs/CTOs; facilitate transfer of complex assays into GMP labs.
- Lead writing/compilation of regulatory documents to support product development and registration.
- Manage a team of 5–10 analysts (onsite and remote).
- Evaluate analytical methods across in-process, drug substance, drug product, and stability testing for siRNA, PMO, and AAV portfolios.
- Liaison with contract laboratories; coordinate method transfers and oversee qualification/validation.
- Generate QC documentation (SOPs, change controls, investigations, OOS/deviations, QC trending).
- Collaborate with Quality Assurance on quality event documentation.
- Write/edit regulatory documents, including eCTD sections for IND, NDA, and BLA.
- Ensure cGMP compliance for product release laboratory operations.
Qualifications:
- MS (Biology/Chemistry/Molecular Biology or related) + 15+ years relevant experience, or PhD + 10+ years relevant experience.
- 10+ years analytical method development experience; advanced HPLC/UPLC and mass spectrometry–based methods.
- Exceptional written/verbal communication.
- Regulatory interaction experience (meetings, PAIs, written responses).
- Product lifecycle management experience across clinical/commercial stages.
- Collaboration and ability to maintain a safe, compliant lab environment.
- Contract lab/vendor experience (CROs/CMOs) highly desirable.
Skills/Requirements:
- Ability to travel ~15%.
- Work onsite at a U.S. facility.
Application instructions:
- Apply if you are solution-oriented, comfortable with ambiguity and candor, and prioritize kindness and integrity.
Responsibilities:
- Represent Analytical Development in high-level internal meetings.
- 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 (with QC leadership/designee).
- Support troubleshooting at CROs/CTOs; facilitate transfer of complex assays into GMP labs.
- Lead writing/compilation of regulatory documents to support product development and registration.
- Manage a team of 5–10 analysts (onsite and remote).
- Evaluate analytical methods across in-process, drug substance, drug product, and stability testing for siRNA, PMO, and AAV portfolios.
- Liaison with contract laboratories; coordinate method transfers and oversee qualification/validation.
- Generate QC documentation (SOPs, change controls, investigations, OOS/deviations, QC trending).
- Collaborate with Quality Assurance on quality event documentation.
- Write/edit regulatory documents, including eCTD sections for IND, NDA, and BLA.
- Ensure cGMP compliance for product release laboratory operations.
Qualifications:
- MS (Biology/Chemistry/Molecular Biology or related) + 15+ years relevant experience, or PhD + 10+ years relevant experience.
- 10+ years analytical method development experience; advanced HPLC/UPLC and mass spectrometry–based methods.
- Exceptional written/verbal communication.
- Regulatory interaction experience (meetings, PAIs, written responses).
- Product lifecycle management experience across clinical/commercial stages.
- Collaboration and ability to maintain a safe, compliant lab environment.
- Contract lab/vendor experience (CROs/CMOs) highly desirable.
Skills/Requirements:
- Ability to travel ~15%.
- Work onsite at a U.S. facility.
Application instructions:
- Apply if you are solution-oriented, comfortable with ambiguity and candor, and prioritize kindness and integrity.