Senior Analytical Chemist

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. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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