Position Summary: The individual will assist in the development of immunoassays and be responsible for performing the necessary experimentation and tasks to enter a project/product into Design Control.The individual will perform and/or support study phases from Discovery to Design Verification, Validation, Transfer and Release.

Essential Job Functions:

• Performs a major role in the generation and transfer of project/product information for the initiation of Design Control projects.
• Establishes Manufacturing processes and Quality Control (QC) procedures for new products.
• Performs the necessary Design Verification studies to support new product launches.
• Performs and/or supports Design Validation studies to support new product launches.
• Performs a major role in the scale-up of new manufacturing processes as needed.
• Assists in the transfer of new technologies, products and/or manufacturing processes into and out of the company.
• Assists in the training of Manufacturing operators, QC technicians, and Quality Assurance (QA) personnel in specific areas of expertise.
• With the assistance of a supervisor, designs experiments to support Discovery, Robustness, Feasibility and Verification studies for new products.
• Interprets results and summarizes data into project reports.
• Performs activities in a GMP/GLP environment.
• Follows all company environmental, health and safety policies, procedures and guidelines, and conducts work in a safe manner.
• Performs other duties as assigned.

Job Specifications (skills, knowledge, special training, certification, license requirements):

• Immunoassay development and manufacturing experience
• Technical problem-solving skills and discipline
• Ability to write clear, concise technical reports
• Analytical and preparatory chromatography experience
• Experience with automated immunoassay analyzers
• Protein modification/chemistry knowledge desirable
• Quality control experience desirable
• Excellent verbal and written communication skills
• Must be detail-oriented and thorough
• Ability to work with various software packages
• Ability to make presentations to various groups of individuals
• Ability to work with potentially hazardous materials
• Manual dexterity and ability to do visual inspections

Education and Work Experience Required:

• Associates Degree or equivalent required; B.S. in Science/Engineering preferred
• 3-5 years of laboratory experience, preferably in the diagnostic or pharmaceutical industries

We offer a competitive compensation and benefits package and a convenient suburban Philadelphia location.

We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted.

Fujirebio Diagnostics is an Equal Employment Opportunity Employer