Scientist II ,

In this GMP laboratory role, you will support analytical method development and validation for HPLC/UPLC. You will maintain instruments, follow validated procedures, and contribute to team efforts while performing independent assessments and proposing next steps. You will author GMP documents and training materials, ensuring compliant documentation across methods, development reports, and validation reports. You will collaborate with cross-disciplinary staff to enable reliable, high-quality results that support product development and quality systems. This is an opportunity to impact analytical rigor in a fast-paced pharmaceutical environment.

• Maintain instrument performance and calibration in a GMP lab setting
• Follow laboratory methods, instrumentation, and safety requirements
• Participate in analytical assay development and validation for HPLC/UPLC
• Work both in teams and independently to assess progress and recommend next steps
• Author GMP documents (methods, development reports, validation protocols/reports)
• Provide training, guidance, and support to staff on areas of expertise

• Experience with analytical method development and validation
• Proficiency with Microsoft Word, Excel, and Outlook
• Experience writing/revising methods, protocols, and reports
• Experience performing testing in a GMP setting
• Hands-on experience with HPLC instrumentation and detection methods
• Familiarity with Waters Empower and/or Dionex Chromeleon chromatography software
• Proficiency with documentation systems for protocols and reports
• Experience working in cross-functional team environments
• Good verbal and written communication, math, and general computer skills

• Team collaboration
• Clear communication
• Instruction and mentoring abilities
• HPLC/UPLC instrumentation and detection
• Colorimetric assays
• Waters Empower