Scientist - Plate Based

Scientist – Plate-Based (Quality Control Laboratory)

This role supports a Quality Control laboratory within a GMP-regulated pharmaceutical manufacturing environment, with a primary focus on biologics-related plate-based analytical testing. The Scientist will lead and support the transfer, qualification, and validation of analytical methods for new products entering the site, ensuring robust, compliant implementation into routine QC operations. The position offers the opportunity to work on high-profile projects, gain exposure to a wide range of analytical methods and technologies, and contribute directly to the delivery of safe and effective products to patients within a science- and risk-based quality culture.

• Support the transfer, qualification, and validation of analytical methods associated with new product introductions into the site.
• Execute method transfer studies, assay qualification protocols, and validation activities in accordance with GMP and internal procedures.
• Assist with preparation and execution of technical protocols, including drafting, reviewing, and finalizing method transfer and validation documents.
• Perform analytical testing using ELISA, plate-based assays, SoloVPE, Slot Blot, and SDS-PAGE to support product release, stability, and characterization activities.
• Analyze test results, interpret data, and ensure accuracy, completeness, and integrity of all analytical outputs.
• Troubleshoot assay performance issues, identify root causes, and support or lead laboratory investigations as needed.
• Support implementation of new testing methods into routine QC operations, including method training and execution support for other analysts.
• Maintain GMP-compliant laboratory records, including contemporaneous documentation of all testing activities and results.
• Review analytical data for completeness, accuracy, and adherence to data integrity principles, including compliance with cGMP and GDP standards.
• Ensure adherence to relevant quality standards, regulatory requirements, and internal policies in all laboratory activities.
• Support inspection readiness efforts by maintaining organized documentation and participating in audits or inspections as required.
• Partner with cross-functional teams such as Quality Control, Quality Assurance, Validation, and Technical Operations to support project timelines and product transfer activities.
• Participate in technical discussions and method transfer meetings, providing scientific input and data-based recommendations.
• Contribute to continuous improvement initiatives within the laboratory, including optimization of methods, workflows, and documentation practices.
• Engage in knowledge sharing and collaboration with colleagues to promote a dynamic, learning-focused laboratory environment.

• Bachelor's degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemistry, or a related scientific discipline.
• 3+ years of experience working in a GMP-regulated pharmaceutical, biotechnology, or biologics laboratory environment.
• Hands-on experience performing ELISA assays in a Quality Control or similar regulated setting.
• Hands-on experience with plate-based assays, including setup, execution, and data analysis.
• Hands-on experience using SoloVPE for analytical measurements.
• Hands-on experience with Slot Blot assays.
• Experience supporting method transfer, qualification, or validation activities for analytical methods.
• Strong understanding of GMP documentation practices and regulatory requirements for QC laboratories.
• Ability to maintain GMP-compliant laboratory records and adhere to cGMP and GDP principles.
• Demonstrated ability to analyze and interpret analytical data with a high level of accuracy and attention to detail.
• Experience troubleshooting assay performance and supporting laboratory investigations.
• Strong communication and collaboration skills to work effectively with cross-functional teams in a regulated environment.

• 5+ years of experience in the pharmaceutical or biologics industry, particularly in Quality Control or analytical laboratories.
• Experience supporting new product introductions, including assay transfer and validation programs.
• Familiarity with SDS-PAGE, including sample preparation, gel running, and data interpretation.
• Experience using LIMS or other electronic laboratory systems for sample management and data recording.
• Experience working with biologics, vaccines, monoclonal antibodies, or protein-based products in a QC or analytical context.
• Exposure to or experience within environments focused on vaccine and monoclonal antibody intermediate manufacturing.
• Demonstrated ability to contribute to continuous improvement initiatives and process optimization in a laboratory setting.
• Interest in learning new analytical methods and technologies and expanding technical expertise over time.

The role is based within a large pharmaceutical manufacturing organization focused on vaccine and monoclonal antibody…