Senior Analytical Chemist

Kelly Services; North Carolina; On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical plan

Dental plan

Vision plan

Telemedicine

Term life Insurance

Whole life Insurance

Accident insurance

Critical illness insurance

Legal plan

Short-term disability

Retirement savings plan

Holiday pay

Job summary

Kelly Science & Clinical is seeking a Senior Analytical Chemist in Raleigh, NC. This fully onsite role focuses on advanced analytical testing, method validation and transfer, investigations, and technical documentation in a cGMP pharmaceutical lab.

You will mentor junior analysts, support stability studies and regulatory submissions, and ensure compliance with FDA, ICH, USP, and ALCOA+ data integrity. Strong chromatography and spectroscopy skills required.

Qualifications

• Bachelor's degree in Chemistry or related field with 5+ years pharma analytics experience; or Master's with 3+ years; or PhD with 1+ year.
• Strong experience in cGMP pharmaceutical labs.
• Expertise with chromatographic and spectroscopic techniques (HPLC, UPLC, GC, UV-Vis, FTIR).
• Experience using Empower, CDS, LIMS, and other lab software systems.
• Solid knowledge of FDA, ICH, USP, and data integrity requirements.

Responsibilities

• Perform complex analytical testing using HPLC, UPLC, GC, UV-Vis, FTIR, dissolution and other techniques.
• Lead method validation, verification, transfer, and troubleshooting activities.
• Lead investigations (OOS, OOT, deviations) and review data for regulatory compliance.
• Prepare technical reports, protocols, and documentation; mentor junior staff.
• Support stability programs and regulatory submissions; assist audits and inspections.

Skills

Analytical chemistry

HPLC/UPLC/GC/UV-Vis/FTIR

cGMP knowledge

Data integrity

Troubleshooting

Education

Bachelor's degree in Chemistry

5+ years pharma analytics experience

Tools

Empower

CDS

LIMS

Job description

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Why Kelly Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, in