BioAssay Project Management Scientist

Overview

In this role you will perform routine and advanced bioassay testing of biologics within a client’s Analytical Service Department, ensuring GMP-compliant data delivery. You will coordinate assay activities, mentor colleagues, and maintain rigorous documentation, while liaising with clients to support multiple programs. This position offers growth in a high-precision, client-focused biotech environment with opportunities to shape method development and overall operational excellence.

Pay / Benefits

• Pension
• Private Medical Insurance
• Annual discretionary bonus
• Birthday holiday entitlement
• Canteen facilities
• Free parking onsite

Responsibilities

• Perform routine, non-routine and stability testing of biologic drug substances using ELISA, cell-based potency assays and Biacore (SPR)
• Coordinate assay activities, manage project priorities and timelines
• Document, analyse and report results using electronic lab notebooks and ELN systems while ensuring regulatory compliance
• Support method development, validation, troubleshooting, trend analysis and OOS investigations
• Act as subject matter expert, provide mentoring and training to colleagues and support recruitment
• Maintain laboratory operations including instrument maintenance, reagent management and SOP/document control
• Build and maintain client relationships through effective communications and delivery of high-quality data
• Promote safety, quality culture and continuous improvement across the lab
• Prepare and update SOPs, protocols, and reports and ensure resources align with project demands

Key requirements

• Degree or higher qualification in a relevant scientific discipline
• Experience in bioanalytical, biopharmaceutical or GMP-regulated labs
• Extensive hands-on experience with ELISA, cell-based potency assays, Biacore (SPR), aseptic techniques and 96-well formats
• Expert knowledge of cell-based assays (Vi-CELL, luminescence-based and flow cytometry) and data interpretation
• GMP/regulatory experience with strong documentation and electronic systems skills
• Ability to troubleshoot analytical methods and instrumentation; apply statistics for investigations
• Strong communication, mentoring skills, client relationship building and cross-functional collaboration
• Proven ability to work in a flexible, customer-focused lab environment

• Strong communication
• Mentoring and training
• Client-focused collaboration
• ELISA
• cell-based potency assays
• Biacore (SPR)

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