Associate Assay Development Scientist - Histopathology

Associate Assay Development Scientist - Histopathology

CellCarta

Wilrijk or Antwerp, Belgium

Summary

The Associate Assay Development Scientist supports the development, verification, and/or validation of (novel) high-quality (single and multiplex) IHC/IF, RISH, FISH, and related assays, predominantly for application in human clinical trials, according to the CellCarta quality system.

The activities are embedded in all stages of the development and validation process (i.e., the design, scheduling, and status follow-up of the development and validation experiments; reporting data for presentation and/or documentation in a ready format) and are executed under the supervision of a more experienced Assay Development Scientist.

Depending on the intended use of the assay, adherence to the requirements for ISO 13485, ISO 15189, CAP/CLIA, GxP, 21 CFR Part 820, and IVDR is required.

Responsibilities

Project Setup and Conduct:

• Learn to effectively develop a standard IHC-type assay;
• Support the AD team during all stages of a project (i.e., start-up, design, scheduling, and status follow-up of development and validation experiments; data analysis and reporting for presentation and/or documentation in a ready format) using existing processes;
• Complete activities under the supervision of an Assay Development Scientist (ADS, Senior ADS, Lead ADS);
• Ensure adherence to applicable quality and regulatory guidelines for the intended use;
• Adhere to the applicable standards and regulations such as ISO 13485, ISO 15189, CAP/CLIA, GxP, 21 CFR Part 820, and IVDR.

Communication and Collaboration:

• Actively engage with internal stakeholders to ensure clear, timely, and transparent information exchange;
• Collaborate with cross-functional teams to address study issues and ensure smooth operations;
• Risk Management;
• Gain exposure to identifying and mitigating project risks;
• Proactively address potential issues, provide updates, and collaborate effectively to achieve project-specific goals.

Learning and Development:

• Participate in formal training sessions to acquire project management skills;
• Gain hands-on experience, supervised by a (Sr.) ADS, e.g., by developing an assay for the internal pipeline;
• Shadow experienced ADS to understand best practices;
• Gradually take on more responsibilities to grow into an ADS position.

Education

• A Master’s degree in a scientific field or relevant experience working in a development/validation environment.

Main Requirements

• Basic knowledge of histology and IHC techniques;
• Eager to learn and adapt;
• Detail-oriented, analytical thinking, and problem-solving;
• Strong organizational skills (timeliness, oversight, and ability to prioritize tasks effectively);
• Strong verbal and written communication skills with internal stakeholders; proactive attitude;
• Maintain a work culture focused on customer service, quality, and meeting deadlines;
• Maintain a positive mindset and demonstrate openness to feedback, fostering a collaborative and growth-oriented work environment.