The Importance of the Role 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.
The Opportunity to Make a Difference - 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.
More about You - 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.
- Experience working with contract laboratories and external vendors (CROs/CMOs) is highly desirable.
What Now? We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Hybrid
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This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $185,600 - $232,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
