Job Title
- Senior Associate Scientist, Anaytical Sciences (Separation Assay) Work Location
- Cranbury NJ Job Summary 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. Job 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. Salary range for this role is 54,700-87,500 Job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs. 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