Development Scientist I

Job Purpose:

The Scientist I is responsible for independently designing, executing, and analyzing laboratory experiments to support the development, optimization, and validation of medical devices and diagnostic assays. This role contributes to the advancement of product development by developing protocols, interpreting data, and collaborating with cross-functional teams to ensure alignment with project goals and regulatory requirements. This position plays a key role in generating technical documentation, supporting risk assessments, and facilitating technology transfer, while maintaining compliance with quality and safety standards.

Key Responsibilities:

• Assist in the design and execution of experiments, including ELISA, ELISPOT, flow cytometry, or molecular assays.

• Prepare biological samples (e.g. serum, plasma, whole blood) for testing and analysis.

• Maintain accurate and detailed laboratory records in compliance with GLP and ISO 13485 standards.

• Analyse experimental data using appropriate statistical tools and software (e.g. Excel, GraphPad Prism).

• Summarise findings in technical reports and contribute to internal documentation for design verification and validation.

• Collaborate with cross-functional teams (engineering, quality, regulatory) to support the development of medical devices.

• Participate in feasibility studies, instrumentation testing, and optimisation of assay performance.

• Follow standard operating procedures (SOPs) and ensure compliance with regulatory requirements (e.g. UK MDR 2002, ISO 13485).

• Support internal audits and contribute to continuous improvement initiatives.

• Ensure proper calibration and maintenance of laboratory equipment.

• Monitor inventory of reagents and consumables and assist in procurement when needed.

• Communicate effectively with team members and contribute to project meetings.

• Share results, insights, and troubleshooting suggestions with senior scientists and project leads.

Working Relationships:

Internal:

• Collaborate with departmental staff on experimental design, data analysis, and technical problem-solving.

• Provide guidance for Technicians on experimental protocols and ensure accurate execution of lab work.

• Work together with Quality Assurance (QA) to ensure experiments and documentation meet quality standards and regulatory requirements.

• Support Regulatory Affairs with the preparation of technical documentation for regulatory submissions.

• Assist Manufacturing in technology transfer activities and provide technical input during scale-up and pilot production.

• Coordinate timelines, deliverables, and resource planning with Project Managers for development projects.

External:

• Engage vendors & equipment suppliers for technical support, training, and troubleshooting of lab instruments and systems.

• Contribute to joint development efforts through data sharing, technical discussions, and experimental support.

Qualifications:

Education: Master’s (minimum) or PhD (preferred) in relevant scientific disciplines such as Immunology, Biomedical Science, Molecular Biology, Biochemistry, Biotechnology, or a related field.

Experience:

• 2-4 years of laboratory experience in immunology, biotech, or medical device product development.

• Hands-on experience with immunoassays (e.g. ELISA, ELISPOT, flow cytometry, or molecular assays), biological sample handling, and data analysis.

• Familiarity with design control, verification and validation, and regulatory documentation in a product development setting.

Technical Skills:

Proficiency in:

• ELISA, ELISPOT, flow cytometry, or molecular assays.

• Sample preparation and handling of human or animal-derived materials.

• Use of laboratory instrumentation and software for data acquisition and analysis.

• Ability to interpret experimental results and contribute to protocol development.

Regulatory & Quality Knowledge:

Understanding of:

• ISO 13485, UK MDR 2002, and IVDR (for diagnostic devices).

• Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).

• Risk assessments, COSHH, and biological safety standards.

Soft Skills:

• Strong analytical and problem-solving skills.

• Excellent attention to detail and documentation accuracy.

• Effective communication and collaboration within cross-functional teams.

• Ability to manage time and priorities in a fast-paced, regulated environment.

What we offer:

• Purposeful work environment

• Dynamic culture in which customers are at the forefront 

• Being part of a highly qualified team that is committed to excellence  

• Access to cutting-edge expertise through which you can make positive impact in the world around us­­

• Extensive benefits including access to private healthcare, life insurance, company pension and more.