Principal Scientist Immunoassay

Resolian; Fordham; On-site; GBP 90,000 - 140,000; Full time

Job summary

Resolian is seeking a Principal Scientist to provide scientific leadership and oversight of the immunoassay group at Fordham. You will ensure high quality methods and sample analysis in line with GLP/GCP, guiding junior staff and promoting best practices.

You will lead method development, drive strategy, mentor scientists, interpret data, support business development, and represent Resolian in external forums.

Qualifications

• Degree in pharmaceutical sciences or equivalent.
• Extensive experience leading development, validation, and application of ligand-binding assays.
• Proven leadership, mentoring, and collaboration across cross-functional teams.

Responsibilities

• Provide oversight of active method development projects in the Immunoassay Bioanalysis group, ensure projects progress to client expectations.
• Lead challenging method development projects with expert knowledge to deliver quality methods on-time.
• Drive the method development strategy to ensure methods are robust, fit-for-purpose and compliant; defend decisions under regulatory scrutiny.
• Mentor scientists working on method development projects; provide scientific guidance and support.
• Provide troubleshooting expertise across multiple methods and platforms.
• Review and interpret method trending data and drive improvements as appropriate.
• Review method establishment and validation data for quality before progression.
• Deliver scientific training within the group and present internally on best practices.
• Maintain knowledge of GLP/GCP standards and regulatory guidelines.

Skills

Scientific leadership

Mentoring scientists

Bioanalytical strategy

GLP/GCP knowledge

Method development oversight

Cross-functional collaboration

Education

Degree in pharmaceutical sciences

Job description

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.

Responsibilities

We are looking for someone who has an innate ability to adopt and adapt new technology and can be an active contributor to the company’s Scientific Strategy. You will also be creative, innovative, agile and collegiate. This means they also promote scientific collaboration, knowledge sharing, and best practice across all Resolian sites; they often explore opportunities to create new service lines or scientific IP, and they can possess expertise that cuts across multiple departments.

Principal Scientists are highly visible and outward interfacing, they are the scientific facade of Resolian, and they use their skills and expertise to advise customers and drive new business.

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.

Responsibilities

What will you be doing?

• Provide oversight of active method development projects in the Immunoassay Bioanalysis group, ensure projects are progressing to client expectations
• 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.
• Mentor scientists working on method development projects; providing scientific guidance and support
• Provide troubleshooting expertise across multiple methods and platforms\
• 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
• Deliver scientific training within the group and present internally on best practices
• Have a good knowledge of the appropriate GLP / GCP standards and latest regulatory guidelines and industry thought leaders.
• Provide scientific support to the Business Development team; review customer requests and advise on feasibility
• Contribute to a culture of continuous improvement
• Build and maintain good working relationships with internal and external clients, management and other scientific staff
• Familiarity with the financial aspects of projects including time and materials costs

Skills, Education & Qualifications

• Degree in pharmaceutical sciences, biochemistry, chemistry, biological sciences, or equivalent industry experience in bioanalysis.
• 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.
• Strong scientific judgement in selecting fit-for-purpose bioanalytical platforms to meet sponsor requirements and regulatory expectations.
• Proven experience operating within a GxP-regulated CRO environment.
• In-depth knowledge of global regulatory guidance and industry best practice for bioanalytical method validation of PK, biomarker, and immunogenicity assays.
• Demonstrated scientific leadership, including mentoring scientists, setting bioanalytical strategy, and collaborating effectively with cross-functional teams.