Immunoassay Development Scientist — GMP Diagnostics

International Executive Service Corps; Malvern (Chester County); On-site; USD 76,000 - 88,000; Full time

Benefits offered by this job

Medical plans

Job summary

Fujirebio Diagnostics Inc. in Malvern, PA seeks a scientist to assist in immunoassay development and enter projects into Design Control. You will perform experiments from Discovery to Design Verification, Validation, Transfer and Release, ensuring compliance in a GMP/GLP environment.

The role requires 3–5 years of lab experience, strong problem-solving, and the ability to write clear reports. Base salary ranges $76,000–$88,000, with comprehensive benefits and potential for advancement.

Qualifications

• Associates degree or equivalent required; B.A./B.S. in Science/Engineering preferred.
• Minimum 3–5 years of laboratory experience, preferably in diagnostic or pharmaceutical industries.
• Experience with immunoassay development and manufacturing is essential.
• Ability to write clear, concise technical reports and present data to varied audiences.

Responsibilities

• Generates and transfers project/product information for Design Control initiation.
• Establishes manufacturing processes and QC procedures for new products.
• Conducts Design Verification studies to support product launches.
• Conducts Design Validation studies for new products.
• Assists in scale-up of manufacturing processes as needed.
• Supports transfer of technologies and processes into/out of the company.
• Trains manufacturing operators, QC technicians, and QA personnel.
• Designs experiments for Discovery, Robustness, Feasibility and Verification studies.
• Interprets results and summarizes data in project reports.
• Works in a GMP/GLP environment and adheres to safety policies.

Skills

Immunoassay development

Analytical chromatography

Technical problem-solving

Report writing

Presentation skills

Software proficiency

Travel flexibility

Education

Associate's degree or equivalent

B.S./B.A. in Science/Engineering preferred

Tools

Automated immunoassay analyzers

Chromatography equipment

Laboratory software

Job description

Fujirebio Diagnostics Inc. in Malvern, PA seeks a scientist to assist in immunoassay development and enter projects into Design Control. You will perform experiments from Discovery to Design Verification, Validation, Transfer and Release, ensuring compliance in a GMP/GLP environment.

The role requires 3–5 years of lab experience, strong problem-solving, and the ability to write clear reports. Base salary ranges $76,000–$88,000, with comprehensive benefits and potential for advancement.