This laboratory-based position consists of approximately 80% hands-on testing and 20% laboratory support activities, with a primary focus on Bioburden and Bacterial Endotoxin Testing (BET).

Responsibilities:

• Perform routine and non-routine microbiological testing of: Raw materials, In-process samples, Drug substance, Drug product, EM/UM samples
• Execute Bioburden Testing and Bacterial Endotoxin Testing (BET) in accordance with approved procedures and compendial requirements.
• Perform testing to support product release, stability studies, validation activities, and manufacturing operations.
• Collect, test, review, and trend utility monitoring samples from pharmaceutical water systems, clean steam, and compressed gas systems.
• Escalate quality or compliance concerns promptly to management.
• Accurately document laboratory activities and results in compliance with cGMP, GDP, and ALCOA+ data integrity principles.
• Identify opportunities for process improvements and laboratory efficiencies.
• Perform routine laboratory housekeeping and inventory management activities.
• Support method qualifications, method transfers, equipment qualifications, and validation activities as assigned.

Requirements:

• Bachelor’s degree in microbiology, Biology, Biotechnology, or a related Life Science discipline with 3+ years of hands-on microbiology laboratory experience
• OR associate degree in a scientific 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 1 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:

• 3+ years of previous experience working in a GMP QC Microbiology Laboratory
• Advanced experience with testing microbiological compendial methods in line with: USP, EP, and JP requirements, ICH guidelines and FDA expectations.
• SAP or ERP, LES/LES-EM, LIMS, WebStatistica, Electronic Laboratory Notebook (ELN) systems, Veeva.
• Experience supporting investigations, CAPAs, deviations, and change controls.

Benefits:

• Comprehensive benefits program

#LI-GSK

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Responsibilities:

• Lead the successful delivery of clinical and commercial biopharmaceutical manufacturing at Upper Merion
• Provide real-time and in-person process monitoring and technical oversight for a 24-7 manufacturing facility
• Design and execute technical studies and protocols to support technology transfer, manufacturing execution, and process improvements
• Lead the introduction and scale-up of primary manufacturing processes transferred from R&D or third-party clients
• Manage relationships between cross-functional stakeholders and the Upper Merion site and global teams
• Monitor process trends, analyze data, and ensure key process parameters and attributes remain within control limits
• Provide technical training to production staff for new equipment and process technologies
• Contribute to the evaluation and feasibility of prospective new products and technologies

Basic Qualifications:

• B.A./B.S. degree in a science field such as biotechnology or chemical engineering, biology, biochemistry, or chemistry
• 4+ years of post-graduate industrial experience in technology/biopharmaceutical process development or biopharmaceutical manufacturing

Preferred Qualifications:

• Upstream experience with large-scale cell culture, cell banking, seed scale-up, and small-scale models
• Downstream experience with bioseparations, purification technologies, or pharmaceutical manufacturing of biologics and large molecules
• Strong interpersonal and matrix leadership skills
• Strong verbal and written communication skills
• Strong analytical and critical thinking skills

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