Resolian
Principal Scientist Immunoassay
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Role Overview
This role is centred on providing scientific leadership and oversight of all the technical aspects within the local Fordham immunoassay group, and throughout the wider Resolian immunoassay teams.
You will be responsible for providing supervision, guidance, and expertise, in order to facilitate the delivery of high quality methods and sample analysis results to our customers in compliance with GLP/GCP.
As a Principal Scientist, you are an expert in scientific technology and experimental practice with peer recognition and credibility. You have a track record of publications and presentations in support of this, which you proactively drive.
Principal Scientists should lead from the lab. They are capable of working creatively and autonomously and they possess a deep technical understanding to develop or troubleshoot methods themselves across all service areas. They demonstrate scientific leadership and clear decision making, directing the work of more junior staff, leading technical training and promotion of good scientific practices.
Key Responsibilities
- Scientific Leadership: Provide oversight of active method development projects in the Immunoassay Bioanalysis group, ensuring projects are progressing to client expectations.
- Method Development: Lead challenging method development projects, using expert knowledge to deliver quality methods on-time. Drive the method development strategy, ensuring methods are developed efficiently, and are robust, fit-for-purpose and compliant. Defend these decisions under regulatory scrutiny.
- Mentorship: Mentor scientists working on method development projects; providing scientific guidance and support.
- Troubleshooting: Provide troubleshooting expertise across multiple methods and platforms.
- Data Review: Review and interpret method trending data and drive improvements as appropriate. Review method establishment and method validation data ensuring methods are of good quality before they progress to the next stage.
- Training: Deliver scientific training within the group and present internally on best practices.
- Regulatory Compliance: Have a good knowledge of the appropriate GLP / GCP standards and latest regulatory guidelines and industry thought leaders.
- Business Development Support: Provide scientific support to the Business Development team; review customer requests and advise on feasibility.
- Continuous Improvement: Contribute to a culture of continuous improvement.
- Relationship Building: Build and maintain good working relationships with internal and external clients, management and other scientific staff.
- Financial Acumen: Familiarity with the financial aspects of projects including time and materials costs.
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External Engagement
- Confidence in regular effective external communication is expected, as is deputising for senior management. This also includes assisting with presentations to new customers and participation in global capability meetings, and directing technical input for new RFP/RFIs.
- Externally, they will build a professional reputation at both personal and corporate levels, through regular podium presentations at key bioanalytical conferences.
- They are always forward-looking, and ready to be vocal to challenge the status quo if they see a better solution.
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Requirements
- Education: Degree in pharmaceutical sciences, biochemistry, chemistry, biological sciences, or equivalent industry experience in bioanalysis.
- Experience: Extensive experience leading the development, validation, and application of ligand-binding assays to support PK, biomarker, and immunogenicity (ADA and NAb) studies across preclinical and clinical programmes.
- Scientific Judgement: Strong scientific judgement in selecting fit-for-purpose bioanalytical platforms to meet sponsor requirements and regulatory expectations.
- Regulatory Environment: Proven experience operating within a GxP-regulated CRO environment.
- Regulatory Knowledge: In-depth knowledge of global regulatory guidance and industry best practice for bioanalytical method validation of PK, biomarker, and immunogenicity assays.
- Leadership: Demonstrated scientific leadership, including mentoring scientists, setting bioanalytical strategy, and collaborating effectively with cross-functional teams.
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