QC Scientist II/III

The Scientist III is an experienced analytical scientist who independently executes complex method development, qualification, and analytical testing activities. This role contributes significantly to technical problem-solving and provides mentorship to junior team members.

Responsibilities

• Independently design and execute complex analytical methods within the assigned platform(s).
• Lead method qualification activities and prepare qualification protocols and reports.
• Perform routine and non-routine analytical testing in support of ongoing projects; analyze, interpret, and present data.
• Author and review SOPs, test methods, and technical/qualification documentation; maintain accurate GMP records.
• Support OOS investigations and contribute to CAPA implementation.
• Provide guidance and mentorship to Scientist I/II and Associate staff; collaborate cross-functionally and communicate technical updates.
• Independently perform and coordinate routine/non-routine GMP and stability testing; verify method, sample, and instrument readiness and escalate atypical results or testing-window risks.

Qualifications

• Bachelor's or Master's degree in Analytical Chemistry, Biochemistry, or related field.
• 5-7+ years of experience in analytical method development and testing.
• Strong background in the assigned platform(s) (HPLC, CE, GC, or compendial assays).
• Experience working in a GMP environment; track record of independently leading method development or qualification activities.
• Stability testing: Independently executes stability timepoints according to approved protocols and testing windows, confirms sample and method readiness, reviews data for consistency/trends, and promptly escalates atypical or potentially reportable results.
• Method lifecycle and investigations: Leads defined qualification activities, authors protocols/reports and test methods, supports transfers and method changes, and provides substantive technical input to OOS/Laboratory Investigations and CAPAs.