Immunoassay Process Design Specialist

Fujirebio; Malvern (Chester County); On-site; USD 76,000 - 88,000; Full time

Benefits offered by this job

Medical plans

401(k) match

Life insurance

Disability insurance

Educational assistance

Employee Assistance Program

Paid time off

Paid holidays

Career advancement

Job summary

Fujirebio Diagnostics Inc. is seeking a knowledgeable professional to assist in developing immunoassay manufacturing processes, create SOPs, and transfer processes to manufacturing in a GMP/GLP environment.

The role includes designing experiments, interpreting results, and compiling project reports to support Design Control projects. The candidate will lead process concept characterization, establish QC procedures for new products, and support scale-up and technology transfer while collaborating

Qualifications

• Strong knowledge of assay standardization and calibrator/control manufacturing processes.
• Immunoassay development and manufacturing experience.
• Strong technical problem-solving skills and discipline.
• Knowledge of microparticle/solid phase chemistry and conjugation chemistry.
• Experience with automated immunoassay analyzers.
• Analytical and preparatory chromatography experience.
• Excellent verbal and written communication skills.
• Must be detail-oriented and thorough.
• Ability to work with various software packages.
• Ability to travel nationally and internationally.

Responsibilities

• Launch development projects focusing on process concept characterization and feasibility.
• Transfer manufacturing process information for Design Control projects.
• Establish manufacturing processes and QC procedures for new products.
• Create reagents, calibrators, and controls for verification lots.
• Support process validation studies and transfers into manufacturing.
• Assist scale-up of new manufacturing processes as needed.
• Facilitate transfer of new technologies and processes.
• Train operators, QC technicians, and QA personnel.
• Follow EH&S policies and work safely.
• Perform other duties as assigned.

Skills

Assay standardization

Immunoassay development

Process transfer

Analytical chemistry

Data interpretation

Documentation

Communication skills

Detail-oriented

Presentation skills

Travel willingness

Education

BS/MS in Science/Engineering

Tools

Automated immunoassay analyzers

Job description

Fujirebio Diagnostics Inc. is seeking a knowledgeable professional to assist in developing immunoassay manufacturing processes, create SOPs, and transfer processes to manufacturing in a GMP/GLP environment.

The role includes designing experiments, interpreting results, and compiling project reports to support Design Control projects. The candidate will lead process concept characterization, establish QC procedures for new products, and support scale-up and technology transfer while collaborating