Bachelor of Science degree with at least 4 years of experience in biopharmaceutical assay development and quality control environment or MS with at least 2 years of experience in biopharmaceutical assay development and quality control environment
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 Biochemist. In this role, you will perform quality sampling, testing, and data review for in-process biopharmaceutical materials, active biopharmaceutical ingredients and finished bulk drug substance.
• Coordinate routine in-process biopharmaceutical materials, bulk biopharmaceutical ingredient, finished biopharmaceutical product and sample testing with testing labs.
• Conduct, documents and review (as needed) routine compendia release samples per SOP.
• Train new analysts for compendia and other analytical test methods per training plans as needed.
• Operate and maintain QC laboratory equipment/instrument in a cGMP-compliant manner.
• Advanced knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.
• Evaluate laboratory SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines. Develop and/or revise laboratory SOPs as required. Must have good technical writing skills and high attention to detail.
• Use QLIMS and SAP as a tool to track laboratory reagents, samples, and testing data. Trend analytical results as needed.
• Lead investigation and assay trouble shooting. Strong interpersonal skills (ability to work in a team environment).
• Lead compendia methods and other analytical method qualification/validation/transfer. Write and/or review protocols and reports.
• Attend weekly meetings to support ongoing and new campaigns.
• Communicate with multiple departments routinely: QA, Project Leads, Materials Management, Analytical testing groups, Regulatory, and Facilities
• Revise product specifications and perform system change procedures. Advanced knowledge working in quality systems: SAP and LIMS based systems
• Trained as an L1 Auditor and participate in >25% of department's L1 Inspections.
You may apply for this position online by selecting the Apply now button.
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We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.