QC Chromatography Senior Scientist

GSK; United States; Hybrid; USD 85,000 - 120,000; Full time

Job summary

GSK in the United States is seeking a highly experienced chromatography specialist to support separation technologies, including Normal and Reverse Phase Chromatography, with multiple detectors. You will design experiments, analyze data, document results, and drive projects to closure while ensuring GMP/compliance.

You will ensure lab safety, lead 5S practices, manage reagent supply, train team members, and act as SME for chromatography methods, including Empower software.

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.
• Lead investigations and Change Control/CAPA tasks and ensure timely closure (Orange Belt certified).
• Process and evaluate complex chromatography data.
• Serve as SME for chromatography methods (performance, acceptance criteria, validation, and compendial requirements).
• Provide SAP/LES input and manage reagents; coordinate creation/qualification of new materials.

Skills

GMP experience

Chromatography

Data analysis

Laboratory management

Education

Bachelor's degree in chemistry/biochemistry/analytical chemistry

Tools

Empower software

Astra software

Job description

Business Introduction

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance.

Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

You will p rovide a high level of scientific expertise to Chromatography team for separation technologies including (but not limited to) Normal and Reverse Phase Chromatography with multiple detection techniques (QDa, PDA, RI, MALS, and CAD), Gel Capillary electrophoresis, etc. Design and implement robust experiments, analyze data, and ensure rigorous documentation of methods, results, and conclusions. Drive projects to closure in support of site goals. Ensure lab processes/tests are safely and efficiently executed and are compliant with GMP/regulatory requirements.

Responsibilities

• Ensure laboratory compliance with EHS policies (ergonomics, waste management, hazardous materials handling, PPE, etc.) and support lab safety and internal and external audits.
• Serve as the Lab Investigation/Change Control/CAPA Task Owner: provide technical expertise, lead implementation, and ensure timely closure (Orange Belt certified).
• 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).
• Serve as backup SAP and LES Business Approver: provide business requirements, review updates, and approve system entries/changes relevant to chromatography workflows. Manage reagent supply chain and coordinate creation/qualification of new materials and reagents as needed
• Drive implementation of new or updated methods - including transfers, corrective/continuous control tasks, CAPA actions, and compendial updates - ensuring protocol adherence and documentation.
• Provide detailed requirements and technical input for SAP and LES implementation/upgrades (master data, test plans, workflows). Serve as Empower SME for the laboratory.
• Troubleshoot equipment and assays (chromatography systems, detectors, autosamplers); coordinate preventive maintenance and escalations to engineering as needed.
• Lead training activities: create/maintain training materials, deliver hands-on training, and maintain competency records for the team.
• Lead and maintain 5S practices within the laboratory to optimize organization, safety, upkeep, and efficiency.

Why You?

Work arrangement

This role is on-site or hybrid depending on site needs. The hiring team will confirm the specific arrangement during the interview. Position may require employees to work in a rotational schedule. This schedule may include holidays, and weekends; overtime may be required.

Basic Qualification

• 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)

Preferred Qualification

• Advanced degree (MS) in chemistry, analytical chemistry or related field.
• Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations, compliance and interfacing with regulatory auditors.
• Familiarity with Astra software for MALS detector analysis
• Sense of urgency, flexibility, and accountability in order to meet goals and deadlines.
• Seasoned knowledge and expertise with chromatography methods and equipment
• Strong skill in analysis and trending of laboratory data
• Ability to work in a highly complex matrix environment with focus on attention to detail.
• Intermediate to advanced computer skills required.
• Proven record of providing excellent internal and external customer service.
• Stay current on developments in the field and GSK-Bio Standards and demonstrate a serious commitme