QC Chromatography Senior Scientist

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

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; its 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 provide 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 commitment to accuracy and quality.
• Maintain transparency and a high level of communication within (and outside) the team
• Strong understanding of analytical methods overseen
• Strong written and verbal communication skills and ability to work collaboratively across functions.

What we value

We look for people who are curious, accountable and open to learning. We support inclusion and welcome different perspectives. If you care about precise work that protects patients and helps teams succeed, we encourage you to apply.

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Problem Solving
• Quality Assurance (QA)
• Quality Control (QC)
• Risk Awareness
• Testing Operations

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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