Analytical Chemist

TekWissen LLC; High Point (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

TekWissen LLC, on behalf of a client in the biotechnology sector, seeks an experienced Scientist II / Analytical Chemist to perform pharmaceutical testing in a GMP-regulated lab environment. The candidate will work with HPLC, GC, and other instrumentation, ensuring data integrity and regulatory compliance.

The role requires hands-on chromatography proficiency, strong documentation, and collaboration with cross-functional teams to support quality control testing and stability studies.

Qualifications

• Bachelor's degree in Chemistry required.
• Minimum 3 years' hands-on HPLC/GC chromatography experience.
• Experience in GMP/FDA-regulated pharma labs.

Responsibilities

• Perform chemical and physical testing of pharmaceutical materials.
• Operate HPLC/GC and other analytical instrumentation.
• Identify OOS results and troubleshoot analytical methods.
• Document procedures and results per GMP/GLP and SOPs.

Skills

HPLC

GC

GMP/FDA

Empower 3

OOS investigations

Data interpretation

Analytical thinking

Documentation skills

Team collaboration

Detail-oriented

Education

Bachelor's degree in Chemistry

Tools

Empower 3 software

Chromatography instruments

Spectroscopy equipment

Job description

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry‑leading brands.

Summary

We are seeking an experienced Scientist II / Analytical Chemist to perform chemical and physical testing of pharmaceutical raw materials, finished products, and stability samples in a GMP‑regulated laboratory environment. The ideal candidate will have strong hands‑on experience with High‑Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), analytical instrumentation, and pharmaceutical quality control testing. This position involves performing routine and non‑routine analytical testing using validated methods, identifying out‑of‑specification results, troubleshooting laboratory instruments, and ensuring accurate documentation in compliance with FDA regulations, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Standard Operating Procedures (SOPs).

Responsibilities

• Perform chemical and physical testing of pharmaceutical raw materials, finished products, and stability samples using internally developed and compendial test methods.
• Conduct analytical testing for product strength, impurities, identity, and other quality attributes using validated analytical methods.
• Operate analytical instrumentation, including High‑Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), spectroscopy equipment, and traditional wet chemistry instruments.
• Perform qualitative and quantitative chemical analysis using chromatography, spectroscopy, and conventional laboratory techniques.
• Identify, investigate, and report out‑of‑specification (OOS) results, unexpected analytical findings, and non‑routine product issues.
• Troubleshoot analytical methods and laboratory instrumentation, recommending appropriate corrective actions.
• Perform routine maintenance and troubleshooting of analytical equipment to ensure accurate and reliable testing.
• Accurately document laboratory testing procedures, analytical observations, calculations, and results in accordance with established laboratory procedures.
• Review, interpret, and communicate analytical data and test results clearly and accurately.
• Maintain laboratory records and report analytical results using approved documentation systems and chromatographic data acquisition software.
• Collaborate with cross‑functional departments to communicate testing results, resolve analytical issues, and support laboratory operations.
• Maintain clean, organized, and safe laboratory workspaces, instruments, and testing materials.
• Ensure compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), FDA regulations, and laboratory safety guidelines.
• Maintain required laboratory compliance standards and participate in continuous quality improvement activities.

Required Skills

• Bachelor's degree in Science in Chemistry is required.
• Minimum 3 years of hands‑on chromatography experience using HPLC and GC is mandatory.
• Experience working in a GMP and FDA‑regulated pharmaceutical laboratory environment.
• Strong knowledge of analytical chemistry, pharmaceutical quality control testing, and validated analytical methods.
• Hands‑on experience with HPLC and GC instrumentation, including operation, troubleshooting, and analytical data interpretation.
• Experience with Empower 3 chromatography data acquisition software preferred.
• Knowledge of spectroscopy, quantitative and qualitative analysis, and traditional wet chemistry techniques.
• Familiarity with pharmaceutical raw material testing, finished product testing, stability testing, and analytical method execution.
• Understanding of out‑of‑specification (OOS) results, analytical investigations, and laboratory troubleshooting procedures.
• Working knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Standard Operating Procedures (SOPs), and FDA regulatory requirements.
• Experience with chromatographic data acquisition systems and common office software applications.
• Strong analytical thinking, independent problem‑solving, and troubleshooting abilities.
• Excellent attention to detail with the ability to maintain accurate laboratory documentation and testing records.
• Strong written and verbal communication skills.
• Ability to work independently, manage laboratory priorities, and collaborate effectively with cross‑functional teams.
• Strong organizational skills and commitment to laboratory safety, data integrity, and regulatory compliance.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.