Senior Chromatography Scientist — GMP QC Leader

Biopharma Careers; Marietta (MS); Hybrid; USD 90,000 - 130,000; Full time

Job summary

GSK US is seeking a Senior Chromatography Scientist to provide high-level scientific expertise for separation technologies and to drive robust experiments in a GMP-regulated lab environment. This role includes method development, data analysis, and compliant documentation aligned with site goals.

You will lead transfers, CAPA actions, and supplier/Vendor support, while serving as a SME for chromatography methods and software such as Empower. On-site or hybrid work arrangements apply in the US.

Qualifications

• Bachelor's degree in chemistry, biochemistry, analytical chemistry or related scientific discipline.
• 5+ years' experience in a laboratory of a high throughput testing environment.
• 5+ years' experience in a GMP/FDA regulated environment.
• 5+ years' experience in Quality Control environment in a Chromatography laboratory (preferably with Empower software).

Responsibilities

• Ensure laboratory compliance with EHS policies and support lab safety and audits.
• Serve as the Lab Investigation/Change Control/CAPA Task Owner; provide technical expertise, lead implementation, and ensure timely closure.
• Responsible for processing and evaluation of complex chromatography data.
• Act as SME for chromatography methods used by the team (method performance, acceptance criteria, troubleshooting, validation, and compendial requirements).
• Provide detailed requirements for SAP and LES implementation/upgrades; Serve as Empower SME for the laboratory.
• Drive implementation of new or updated methods, including transfers, CAPA actions, and compendial updates.
• Troubleshoot equipment and assays; coordinate preventive maintenance and escalations to engineering.
• Lead training activities and maintain competency records.
• Lead and maintain 5S practices within the laboratory to optimize organization and safety.

Skills

Chromatography

GMP Compliance

Lab Safety

Documentation

QA/QC

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Problem Solving

Risk Awareness

Education

Bachelor's degree in chemistry, biochemistry, analytical chemistry or related scientific discipline

Advanced degree (MS) in chemistry, analytical chemistry or related field

Tools

Empower

Astra software for MALS detector analysis

SAP/ LES

Job description

GSK US is seeking a Senior Chromatography Scientist to provide high-level scientific expertise for separation technologies and to drive robust experiments in a GMP-regulated lab environment. This role includes method development, data analysis, and compliant documentation aligned with site goals.

You will lead transfers, CAPA actions, and supplier/Vendor support, while serving as a SME for chromatography methods and software such as Empower. On-site or hybrid work arrangements apply in the US.