QC Chromatography Senior Scientist

GSK•Marietta, PA

8d•Hybrid

About The Position

This role will provide a high level of scientific expertise to the 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. The scientist will design and implement robust experiments, analyze data, and ensure rigorous documentation of methods, results, and conclusions. This role will drive projects to closure in support of site goals and ensure lab processes/tests are safely and efficiently executed and are compliant with GMP/regulatory requirements.

Requirements

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)

Nice To Haves

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.

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.