Director, Analytical Development

Sarepta Therapeutics•Bedford, MA

1d•Hybrid

About The Position

The Director of Analytical Development will spearhead the advancement of analytical methods and control strategies critical to our siRNA and antisense oligonucleotides portfolio. The role will represent Analytical Development on CMC teams and provide leadership that will be crucial from R&D transition to commercialization, ensuring robust support throughout the product lifecycle. The individual will have demonstratable expertise in managing analytical activities at external drug substance and drug product manufacturing sites, and providing chemistry expertise for RNA therapeutics. In addition, the individual will offer comprehensive experience in product characterization and comparability assessments. Additionally, the Director will lead the writing and compilation of regulatory documents to support product development and registration.

Requirements

PhD in Chemistry, Chemical Engineering, Pharmaceutical Engineering, or a related field preferred.
Minimum of 7 years of experience in pharmaceutical/biopharmaceutical analytical development.
Minimum of 5 years of experience in a managerial capacity.
Extensive expertise in analytical method development and control strategy for RNA-based therapeutics.
In-depth knowledge of analytical techniques and regulatory requirements.
Strong analytical and problem-solving abilities.
Proven track record in preparing Module 3 sections for regulatory submissions.
Demonstrated ability in leading cross-functional teams and projects.
Strong collaboration and teamwork skills, with the ability to support cross‑functional peers and maintain a safe, efficient, and compliant laboratory environment.
Capability to foster innovation and integrate new technologies into analytical development practices.

Nice To Haves

Experience working with contract laboratories and external vendors (CROs/CMOs) is highly desirable.

Responsibilities

Provide leadership and mentorship to a team of scientists and analysts
Characterize new products to support regulatory submissions and lifecycle comparability.
Ensure process for documenting and transferring analytical methods to Quality Control and external facilities are in place.
Drive innovation in analytical method development for oligonucleotide therapeutics
Collaborate with cross-functional teams including process development, MS&T, QC, QA and regulatory affairs.
Manage relationships with CDMOs, CTLs, and other external partners.
Oversee critical sections of IND and NDA submissions and respond to health authority inquiries.