- Rahway, New Jersey, United States
- Principal
- $157K–$247K per year
- 8+ years
- Visa sponsorship
Lead integrated CMC program for early-stage biologics, providing strategic, technical, and operational direction across cross-functional teams to advance pipeline biologics from candidate selection through early clinical development and FIH milestones.
Compensation
The salary range for the primary location of this role is: $156,900.00 - $247,000.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Responsibilities
- Lead and operationalize matrixed CMC project teams
- Drive strategic and operational alignment across key CMC interfaces
- Proactively identify program vulnerabilities and formulate contingency plans
- Define and champion phase-appropriate analytical control strategies
- Guide and contribute to technical authoring of regulatory filings
Requirements
- Ph.D. in Analytical Chemistry, Biochemistry, Chemical/Biochemical Engineering, Biophysics, or related scientific discipline
- M.S. in related scientific discipline
- B.S. in related scientific discipline