B.S. degree in a science field required
4-5 years' with B.S. or 2-3 years' with M.S. of relevant experience in cell culture and assay development for bioassays or ELISAs in an R&D, biopharmaceutical manufacturing or Quality Control environment
B.S. degree in a science field required
• Must have excellent technical writing skills and high attention to detail
• Knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.
• Able to seek additional tasks or non-routine functions and accomplish them with minimal supervision
• Overcome minor conflicts with priorities; consult supervisor regarding major conflicts
• Proactive in attempting to learn philosophy/ underlying principle behind relevant tests/SOPs and their intended samples
Why GSK? Because GSK's Biopharm business vision is to leverage its experience and technical capabilities to launch, supply, and manage Biopharmaceutical products around the world. It will fulfill GSK's Mission to Do More, Feel Better, and Live Longer by living its values: Integrity: Always doing the right thing; Commitment to the Patient: Making the Patient the #1 Priority; Customer Service: Commit to delivering on promises to internal & external customers; Compliance - Being accountable for quality and safety.
GSK Biopharm in Rockville MD has an opening for a Senior Biologist. Reporting to the Quality Control Supervisor, in this role you will be the Senior Biologist performing cell-based quality control testing and data review for bulk biopharmaceutical ingredients and finished biopharmaceutical products under cGMP conditions.
• Perform and document routine testing duties including: testing samples for product release and stability; comparability and non-GMP studies.
• Perform critical reagent and method qualifications, method validation/transfer. Write protocols and reports as needed.
• Operate and maintain QC laboratory equipment and instrument in a cGMP-compliant manner.
• Work through obstacles; perform and complete routine assignments according to written procedures with minimal supervision
• Evaluate laboratory SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines. Develop or revise laboratory SOPs as required.
• May assist QC Scientist in cell-based assay development and optimization.
• Assist in investigations and assay troubleshooting.
• Train other analysts as required.
• Meet laboratory safety requirements.
You may apply for this position online by selecting the Apply now button.
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