QC Immunology Senior Scientist

GSK•Marietta, PA

16h•Hybrid

About The Position

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. You will provide a high level of scientific expertise to Immunology team for assays including (but not limited to) ELISA, Colorimetric Assay, Immunodiffusion, Western Blot, Particle Sizing, and PCR. 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.

Requirements

Bachelor’s degree in immunology, biology, biochemistry, or related scientific discipline.
5+ years’ experience in a laboratory of a high volume, rapid turnaround testing.
5+ years’ experience in a GMP/FDA regulated environment.
3+ years’ experience in Quality Control environment in an Immunology/Colorimetry/PCR laboratory (preferably with Softmax Pro Software)

Nice To Haves

M.S degree in immunology, biology, biochemistry, or related scientific discipline.
Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations, compliance and interfacing with auditors.
Serve as an SME (subject matter expert) in technical areas in order to provide information to others.
Ability to interface with regulatory auditors.
Understand when a topic must be escalated and carry out escalation.
Sense of urgency, flexibility, and accountability.
Executive capability and leadership to manage people and field projects teams.
Ability to communicate at all levels.
Willing to travel abroad.
Ability to work in a complex matrix environment.
Must be a committed team player prepared to work in and embrace a team-based culture.
Ability to follow written procedures and document results in a neat and precise manner.
Advanced computer skills preferred.
Proven record of providing excellent internal and external customer service.
Stay current on developments in the field and GSK-Bio Standards.
Work within a Multi-skilled team.
Maintain attention to detail, while completing multiple or repetitive tasks.
Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
Maintain a high level of integrity while balancing multiple priorities and responsibilities.

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 Deviation/Change Control/CAPA coordinator: provide technical expertise, lead implementation, and ensure timely closure (Orange Belt certified).
Manage reagent supply chain and coordinate creation/qualification of new materials and reagents (specs, stability, vendor qualification).
Act as SME for ELISA, colorimetry, PCR, Western Blot assays used by the team (method intent, acceptance criteria, troubleshooting, validation and compendial requirements).
Serve as SAP and LES Business Approver: provide business requirements, review updates, and approve system entries/changes relevant to assay workflows.
Drive implementation of new or updated methods — including transfers, corrective/continuous control (CC) 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).
Review and approve release data and batch records for testing performed by the immunology team, ensuring accuracy and compliance with GMP.
Troubleshoot equipment and assays (plate readers, thermocycler, western blot apparatus); 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, and efficiency.