Senior Analytical Chemist

Schedule: Fully Onsite | Monday-Friday | Normal Business Hours

The Senior Analytical Chemist provides advanced analytical support within a cGMP-regulated pharmaceutical laboratory. This role is responsible for analytical testing, method validation and transfer, laboratory investigations, stability studies, troubleshooting, and technical documentation. The Senior Analytical Chemist serves as a subject matter expert, mentors junior analysts, and supports continuous improvement, regulatory compliance, and inspection readiness.

• Perform complex analytical testing using HPLC, UPLC, GC, UV-Vis, FTIR, dissolution, and other analytical techniques.
• Execute and review method validation, verification, transfer, and troubleshooting activities.
• Lead investigations involving OOS, OOT, deviations, atypical results, and laboratory non-conformances.
• Analyze scientific data and prepare technical reports, protocols, assessments, and laboratory documentation.
• Mentor and train junior laboratory personnel on analytical techniques and data integrity requirements.
• Support stability testing programs and trend analytical data.
• Participate in product lifecycle activities, including change controls and continuous improvement initiatives.
• Support regulatory submissions, audits, and inspection readiness activities.
• Ensure compliance with cGMP, GDP, ALCOA+, USP, EP, and ICH guidelines.
• Review laboratory data for accuracy, completeness, and regulatory compliance.
• Support laboratory instrumentation maintenance, qualification, and calibration.
• Collaborate with Quality Assurance, Manufacturing, Regulatory Affairs, Technical Services, and R&D.
• Perform additional duties as assigned.

• Bachelor's degree in Chemistry or a related scientific discipline with 5+ years of pharmaceutical analytical laboratory experience;
  Master's degree with 3+ years of experience; or PhD with 1+ year of relevant experience.
• Strong experience working in cGMP pharmaceutical laboratories.
• Expertise with chromatographic and spectroscopic techniques, including HPLC, UPLC, GC, UV-Vis, and FTIR.
• Experience using Empower, CDS, LIMS, and other laboratory software systems.
• Strong knowledge of FDA, ICH, USP, and data integrity requirements.
• Demonstrated troubleshooting, root cause investigation, and analytical problem-solving skills.
• Excellent written and verbal communication skills.

• Experience with analytical method validation, verification, and transfer.
• Experience supporting stability studies and shelf-life evaluations.
• Project leadership experience.
• Experience supporting regulatory inspections and audits.
• Knowledge of ICH Q2, Q14, and analytical lifecycle management principles.
• Fully onsite position based in Raleigh, NC.
• Standard Monday-Friday business hours.
• Laboratory-based role within a cGMP-regulated pharmaceutical environment.
• Requires working with laboratory instrumentation, chemicals, and appropriate PPE.
• Combination of laboratory testing, data analysis, and technical documentation.
• Occasional schedule flexibility may be required to support project deadlines or regulatory inspections.
• May provide technical guidance and mentoring to junior laboratory personnel.