Associate Director, Analytical Development
Ladders · United States · 4 days ago
RemoteRemoteManagement$150k–$195k/yrFull-time
Responsibilities
- Provide technical leadership and manage method development, validation, and transfer at CRO/CMOs
- Oversee specification setting for drug substance and drug product at CDMOs/CROs
- Perform technical reviews and approve analytical method validation and method transfer protocols
- Manage development activities including IPC and release testing
- Lead troubleshooting of OOS and OOT root causes by providing corrective actions
- Write technical reports on various chemistry-related subjects
Qualifications
- B.S. in Chemistry, Biochemistry, or related Life Sciences discipline required
- 8+ years of experience in analytical development, validation, and transfer in Biotech or Pharmaceutical industry
- Direct knowledge of HPLC, GC, MS, NMR, IR, dissolution, and other analytical methods
- Experience managing analytical development activities with CRO/CMOs
- Strong verbal and written communication skills
Benefits
- Comprehensive health and financial benefits for eligible employees and dependents
- Wellness and employee support programs
- Life insurance and disability coverage
- Retirement plans with employer match
- Generous paid time off offerings