Senior Analytical Chemist

Kelly Science, Engineering, Technology & Telecom; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom seeks a Senior Analytical Chemist for a fully onsite role in Raleigh, NC. You'll lead advanced analytical testing, method validation/transfer, and investigations in a cGMP pharmaceutical lab.

Responsibilities include mentoring junior analysts, supporting stability studies, regulatory submissions, audits, and continuous improvement while ensuring ALCOA+ data integrity and compliance with USP/ICH guidelines.

Qualifications

• Bachelor's degree in Chemistry or related, with 5+ years pharma analytical lab experience; Master's 3+ years; PhD 1+ year.
• Experience in cGMP pharmaceutical laboratories.
• Expertise with chromatographic and spectroscopic techniques, including HPLC, UPLC, GC, UV-Vis, 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.

Responsibilities

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

Skills

Analytical chemistry

Regulatory compliance

Troubleshooting

Data integrity

Documentation

Mentoring

Education

Bachelor's degree in Chemistry or related

Master's degree with 3+ years experience

PhD with 1+ year experience

Tools

Empower

CDS

LIMS

Job description

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

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.
• 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.