Senior Analytical Chemist
2 days ago
Raleigh
Job Description Senior Analytical Chemist Location: Raleigh, NC Schedule: Fully Onsite | Monday–Friday | Normal Business Hours Salary: $85,000–$115,000 Position Summary 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. Key Responsibilities • 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. Qualifications Required • 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. Preferred • 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. Work Environment • 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. 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