Job Title - Principal Scientist, Analytical Sciences
Work Location - Cranbury NJ
Job SummaryServe as a technical leader responsible for analytical strategy development and execution across biologics programs from early development through commercialization. Provide scientific leadership in analytical method development, characterization, validation, lifecycle management, and regulatory support.
Job Responsibilities- Serve as Analytical Sciences technical lead for client programs and internal development initiatives.
- Develop and implement analytical control strategies supporting biologics throughout the product lifecycle.
- Provide leadership for analytical method development, qualification, validation, transfer, and lifecycle management.
- Lead analytical characterization activities including protein characterization, potency assays, impurity assessment, and stability-indicating methods.
- Provide technical oversight for mass spectrometry-based characterization including peptide mapping, intact mass analysis, and PTM characterization.
- Lead investigations related to analytical, manufacturing, and product quality issues including OOS, deviations, and change controls.
- Support IND, BLA, NDA, and MAA regulatory submissions and agency responses.
- Provide technical oversight of CROs, CMOs, and contract laboratories.
- Mentor junior scientists and provide technical guidance across Analytical Sciences teams.
- Author and review technical reports, protocols, validation documents, and regulatory submissions.
Qualifications- Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Molecular Biology, or related scientific discipline.
- 10+ years of biopharmaceutical analytical development experience supporting biologics.
- Demonstrated experience leading analytical development programs and cross-functional initiatives.
- Extensive experience in protein characterization, analytical method lifecycle management, and regulatory support.
- Expertise with LC-MS/MS, peptide mapping, intact mass analysis, HPLC/UPLC, SEC, IEX, ELISA, cell-based assays, and related analytical technologies.
- Strong leadership, communication, strategic thinking, and mentoring skills.
The anticipated salary for this position is $90,000 - $140,000
