QC Immunology Senior Scientist
GSK
14 hours ago
Remote friendly (Marietta, PA)
United States
Operations
Position Summary
- Provide high level scientific expertise to the Immunology team for assays including ELISA, colorimetric assays, immunodiffusion, Western blot, particle sizing, and PCR.
- Design and implement robust experiments, analyze data, and document methods/results/conclusions.
- Drive projects to closure to support site goals.
- Ensure lab processes/tests are executed safely and comply with GMP/regulatory requirements.
Responsibilities
- Ensure lab compliance with EHS policies and support safety and internal/external audits.
- Serve as Deviation/Change Control/CAPA coordinator; lead implementation and ensure timely closure (Orange Belt certified).
- Manage reagent supply chain; coordinate creation/qualification of new materials/reagents.
- Act as SME for ELISA, colorimetry, PCR, and Western blot (method intent, acceptance criteria, troubleshooting, validation/compendial requirements).
- Serve as SAP and LES Business Approver; provide requirements and approve assay-workflow system entries/changes.
- Implement new/updated methods (transfers, CC tasks, CAPA actions, compendial updates) with adherence to protocols.
- Provide technical input for SAP/LES upgrades (master data, test plans, workflows).
- Review/approve release data and batch records for immunology testing.
- Troubleshoot equipment/assays; coordinate preventive maintenance and escalations.
- Lead training and maintain competency records.
- Lead/maintain 5S in the lab.
Basic Qualifications
- Bachelor’s in immunology/biology/biochemistry or related field.
- 5+ years lab experience in high volume, rapid turnaround testing.
- 5+ years in GMP/FDA regulated environment.
- 3+ years in QC Immunology/Colorimetry/PCR (preferably Softmax Pro).
Preferred Qualifications
- M.S.
- Knowledge of GMP/NIH/FDA and other regulatory requirements; interface with auditors.
- SME capability; escalation judgment; urgency/accountability.
- Leadership, communication, travel abroad, matrix environment experience.
How to apply
- Submit resume and a note describing a recent assay troubleshooting, validation, or investigation you led (challenge, approach, outcome).
- Provide high level scientific expertise to the Immunology team for assays including ELISA, colorimetric assays, immunodiffusion, Western blot, particle sizing, and PCR.
- Design and implement robust experiments, analyze data, and document methods/results/conclusions.
- Drive projects to closure to support site goals.
- Ensure lab processes/tests are executed safely and comply with GMP/regulatory requirements.
Responsibilities
- Ensure lab compliance with EHS policies and support safety and internal/external audits.
- Serve as Deviation/Change Control/CAPA coordinator; lead implementation and ensure timely closure (Orange Belt certified).
- Manage reagent supply chain; coordinate creation/qualification of new materials/reagents.
- Act as SME for ELISA, colorimetry, PCR, and Western blot (method intent, acceptance criteria, troubleshooting, validation/compendial requirements).
- Serve as SAP and LES Business Approver; provide requirements and approve assay-workflow system entries/changes.
- Implement new/updated methods (transfers, CC tasks, CAPA actions, compendial updates) with adherence to protocols.
- Provide technical input for SAP/LES upgrades (master data, test plans, workflows).
- Review/approve release data and batch records for immunology testing.
- Troubleshoot equipment/assays; coordinate preventive maintenance and escalations.
- Lead training and maintain competency records.
- Lead/maintain 5S in the lab.
Basic Qualifications
- Bachelor’s in immunology/biology/biochemistry or related field.
- 5+ years lab experience in high volume, rapid turnaround testing.
- 5+ years in GMP/FDA regulated environment.
- 3+ years in QC Immunology/Colorimetry/PCR (preferably Softmax Pro).
Preferred Qualifications
- M.S.
- Knowledge of GMP/NIH/FDA and other regulatory requirements; interface with auditors.
- SME capability; escalation judgment; urgency/accountability.
- Leadership, communication, travel abroad, matrix environment experience.
How to apply
- Submit resume and a note describing a recent assay troubleshooting, validation, or investigation you led (challenge, approach, outcome).