QC Senior Scientist

GSK; Upper Merion Township (Montgomery County); On-site; USD 90,000 - 130,000; Full time

Job summary

GSK is seeking a QC Senior Scientist – Microbiology to lead microbiological testing of drug product, drug substance, and materials. You will review data, mentor analysts, and support regulatory submissions.

Some weekend work and cross-functional collaboration with QA, Manufacturing, and Technical Operations are required. Responsibilities include bioburden and BET testing, growth promotion, instrument lifecycle support, and authoring SOPs while ensuring regulatory compliance and data integrity

Qualifications

• Bachelor’s or Master’s degree in a life science field with GMP experience.
• Experience in GMP/GxP pharmaceutical/biotech environments.
• Hands-on microbiology including BET and bioburden testing.

Responsibilities

• Conduct microbiological testing of samples (raw materials, drug product, drug substance).
• Perform bioburden and BET testing and routine/non-routine quality disposition.
• Lead investigations, trend data review, and SOP/document updates.
• Mentor analysts, support regulatory submissions and audits.

Skills

Data integrity

Detail-oriented

Digital fluency

GxP regulations

Lean management

Problem solving

Quality assurance

Quality control

Risk awareness

Testing operations

Education

Bachelor’s degree in Microbiology or Life Science

Master’s degree in Microbiology or Life Science

Tools

SAP/ERP

LES/LES-EM

LIMS

ELN

WinKQCL

PyroTec PRO

Job description

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 requires open availability with the understanding that some weekend work will be required, additionally this role 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.

Why you?

Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:

• 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).

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• 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.
• Ability to work independently and collaboratively in a team environment with minimal supervision.
• Excellent organizational and task management skills.
• Advanced understanding of microbiological methods and laboratory techniques.
• Working knowledge of automation platforms.
• Strong data analysis, trending, technical writing, and written and verbal communication skills.
• Effective problem solving and critical thinking skills.
• Ability to work weekends as part of a F-M schedule #LI-GSK Skills Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Quality Assurance (QA), Quality Control (QC), Risk Awareness, Testing Operations

Benefits Summary

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail]. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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Our Purpose

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.