- Rahway, New Jersey, United States
- Full-time · Principal
- $157K–$247K per year
- 8+ years
- Visa sponsorship
A high-visibility role combining integrated cross-functional program leadership with deep subject-matter expertise (SME) in biologics analytical development, advancing pipeline biologics from candidate selection through early clinical development.
Compensation
$156,900 - $247,000
Responsibilities
- Serve as the Early-Stage Development and Commercialization Team (DCT) Lead for assigned pipeline biologics, holding accountability for integrated CMC development strategy, milestone readiness, and cross-functional alignment.
- Lead and operationalize matrixed CMC project teams; establish transparent team structures, functional working groups, clear decision rights, and milestone-driven timelines.
- Drive strategic and operational alignment across key CMC interfaces, including Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, and external partners.
- Proactively identify program vulnerabilities, evaluate cross-functional trade-offs, and formulate data-driven contingency plans.
- Define and champion phase-appropriate analytical control strategies, product characterization workflows, and specification-setting rationales for early-phase biological modalities.
Requirements
- Ph.D. in Analytical Chemistry
- Biochemistry
- Chemical/Biochemical Engineering
- Biophysics
- related scientific discipline