Sr. Associate Scientist, Analytical Sciences
WuXi Biologics · Cranbury, NJ · 2 wk ago
AnalystFull-time
About the role
Perform analytical method development, optimization, qualification, and testing activities utilizing HPLC and capillary electrophoresis platforms to support biologics development, characterization, stability, and lifecycle management programs.
Responsibilities
- Independently perform analytical testing using HPLC- and CE-based methods to support biologics development programs.
- Develop, optimize, qualify, and transfer analytical methods including SEC, IEX, HIC, RP-HPLC, CE-SDS, and cIEF.
- Design and execute studies to improve method robustness, resolution, sensitivity, and reproducibility.
- Perform protein characterization, aggregation analysis, fragmentation analysis, purity assessments, and impurity evaluations.
- Support analytical method qualification, transfer, and lifecycle management activities.
- Analyze and interpret analytical data and communicate findings to project teams.
- Support stability studies, comparability assessments, formulation development, and process development activities.
- Troubleshoot analytical methods, instrumentation, and testing-related issues.
- Author and review SOPs, test methods, protocols, and technical reports.
- Utilize Empower and related chromatography software for data acquisition, review, and reporting.
- Collaborate with cross-functional teams and support GMP activities as required.
Qualifications
- BS in a relevant scientific discipline with 3+ years of experience, or MS with 0-1 years of analytical development experience.
- Experience supporting biologics, antibodies, fusion proteins, or ADC programs preferred.
- Strong hands-on experience with SEC, HIC, IEX, RP-HPLC, CE-SDS, cIEF, and Empower software.
- Experience with Waters and/or Agilent HPLC systems.
- Experience with analytical method development, optimization, qualification, and troubleshooting.
- Strong data analysis, technical writing, and communication skills.
- Knowledge of GMP and analytical lifecycle management principles preferred.
Pay
Salary range for this role is $54,700‑$87,500.