Director, Analytical Development

The Director of Analytical Development will spearhead analytical methods and control strategies for siRNA and antisense oligonucleotides, representing Analytical Development on CMC teams and providing leadership from R&D transition to commercialization.

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

Qualifications/Skills:
- PhD in Chemistry, Chemical Engineering, Pharmaceutical Engineering, or related field (preferred)
- 7+ years’ experience in pharmaceutical/biopharmaceutical analytical development
- 5+ years’ experience in a managerial capacity
- 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 preparing Module 3 sections for regulatory submissions
- Demonstrated ability leading cross-functional teams and projects
- Strong collaboration and ability to maintain safe, efficient, compliant laboratory environment
- Ability to foster innovation and integrate new technologies
- Experience with CROs/CMOs/contract laboratories (highly desirable)

Application instructions:
- Candidates must be authorized to work in the U.S.