QC Senior Scientist (Microbiology)

GSK•King of Prussia, PA

3d•Onsite

About The Position

The QC Senior Scientist – Microbiology is responsible for Test drug product and drug substance samples for release, in-process, and stability as well as sample, test, and release raw materials for production use. The Senior Scientist also performs data review and trend analysis. In addition, the Senior Scientist supports equipment management and lab duties, mentors and trains other analysts, supports product regulatory submissions and inspections, and coordinates laboratory activities for the team. This position operates on a Friday–Monday weekend shift schedule and requires the ability to work independently while effectively collaborating across Quality, Manufacturing, and Technical Operations. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Conduct microbiological testing of laboratory samples (raw materials, drug product, drug substance, in-process materials, water, etc.) Complete bioburden testing and bacterial endotoxin testing (BET) in accordance with approved procedures and compendial requirements. Carry out routine and non-routine testing for quality disposition in support of manufacturing operations, technical transfers, and special studies within the product supply chain. Execute growth promotion tests, media qualification, biological Indicators qualification. Perform microbial identification, including gram-stain and latex tests. Manage samples and associated documentation throughout their lifecycle, ensuring compliance in both physical and electronic systems. Author and execute protocol studies, as applicable. Participate in and/or lead laboratory investigations, deviations, and assay troubleshooting with minimal supervision. Author, review, and revise SOPs, user requirement specifications (URS), and other controlled documents. Review and approve laboratory data to ensure accuracy, completeness, and compliance with regulatory standards. Perform routine departmental GMP activities and maintain laboratory readiness, including, work orders, management monitoring inspections, 5S practices, DMAIC investigations, orange belt certification, change controls, inventory management, etc.) Support and lead analytical and instrument lifecycle activities, technical transfers, and validation processes to maintain robust laboratory operations. Serve as a technical subject matter expert (SME) in multiple laboratory techniques, provide mentorship to junior team members, and support internal and external audits as required. Complete other duties as assigned.

Requirements

Bachelor's degree in Microbiology, Biology, Biotechnology, or a related Life Science discipline with 5+ years of hands-on microbiology laboratory experience OR Master's degree in Microbiology, Biology, or a related Life Science discipline with a minimum of 3 year of hands-on microbiology experience in a GMP-regulated environment.
Experience working in a GMP/GxP-regulated pharmaceutical, biotechnology, medical device, or healthcare environment.
Experience performing Bioburden and Bacterial Endotoxin Testing (BET).
Ability to work independently and collaboratively in a team environment with minimal supervision.
Excellent organizational and task management skills.
Strong data analysis, trending, technical writing, and written and verbal communication skills.
Effective problem solving and critical thinking skills.

Nice To Haves

Experience with laboratory systems preferred, including: SAP/ERP, LES/LES-EM, LIMS, ELN, and analytical instrument software (WinKQCL, PyroTec PRO). Proficient in Microsoft Excel, Word, PowerPoint, and Veeva.
Working knowledge of cGXP, ICH guidelines, FDA, USP/EP/JP compendial requirements, and data integrity principles.
Advanced understanding of microbiological methods and laboratory techniques.
Working knowledge of automation platforms.
Ability to work weekends as part of a F-M schedule

Responsibilities

Conduct microbiological testing of laboratory samples (raw materials, drug product, drug substance, in-process materials, water, etc.)
Complete bioburden testing and bacterial endotoxin testing (BET) in accordance with approved procedures and compendial requirements.
Carry out routine and non-routine testing for quality disposition in support of manufacturing operations, technical transfers, and special studies within the product supply chain.
Execute growth promotion tests, media qualification, biological Indicators qualification.
Perform microbial identification, including gram-stain and latex tests.
Manage samples and associated documentation throughout their lifecycle, ensuring compliance in both physical and electronic systems.
Author and execute protocol studies, as applicable.
Participate in and/or lead laboratory investigations, deviations, and assay troubleshooting with minimal supervision.
Author, review, and revise SOPs, user requirement specifications (URS), and other controlled documents.
Review and approve laboratory data to ensure accuracy, completeness, and compliance with regulatory standards.
Perform routine departmental GMP activities and maintain laboratory readiness, including, work orders, management monitoring inspections, 5S practices, DMAIC investigations, orange belt certification, change controls, inventory management, etc.)
Support and lead analytical and instrument lifecycle activities, technical transfers, and validation processes to maintain robust laboratory operations.
Serve as a technical subject matter expert (SME) in multiple laboratory techniques, provide mentorship to junior team members, and support internal and external audits as required.
Complete other duties as assigned.