Senior Analytical Scientist, Biologics & Strategy

WuXi Biologics; Cranbury Township (NJ); On-site; USD 90,000 - 140,000; Full time

Job summary

WuXi Biologics in Cranbury, NJ is seeking a Principal Scientist, Analytical Sciences to act as a technical leader for analytical strategy development and execution across biologics programs from early development through commercialization.

You will lead analytical method development, qualification, validation, transfer, and lifecycle management, and provide regulatory support for IND, BLA, NDA, and MAA processes. Mentoring junior scientists and overseeing CROs/CMOs are also key aspects.

Qualifications

• Ph.D. in a relevant scientific discipline as listed.
• 10+ years of biopharmaceutical analytical development experience for biologics.
• Demonstrated leadership in analytical development programs and cross-functional initiatives.

Responsibilities

• Serve as Analytical Sciences technical lead for client programs and internal development initiatives.
• Develop and implement analytical control strategies for biologics across 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.

Education

Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Molecular Biology, or related scientific discipline

Tools

LC-MS/MS

peptide mapping

intact mass analysis

HPLC/UPLC

SEC

IEX

ELISA

cell-based assays

Job description

WuXi Biologics in Cranbury, NJ is seeking a Principal Scientist, Analytical Sciences to act as a technical leader for analytical strategy development and execution across biologics programs from early development through commercialization.

You will lead analytical method development, qualification, validation, transfer, and lifecycle management, and provide regulatory support for IND, BLA, NDA, and MAA processes. Mentoring junior scientists and overseeing CROs/CMOs are also key aspects.