Principal Scientist I, Analytical Sciences

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

Job Title - Principal Scientist, Analytical Sciences

Work Location - Cranbury NJ

Job Summary

Serve 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

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.