Process Design Scientist

About Us

For 75 years, Fujirebio Diagnostics Inc., is a leading worldwide biotechnology Company and the innovation engine behind diagnostic breakthroughs that reach patients worldwide. Our in vitro diagnostics (IVD) technology powers critical tests across the globe’s leading diagnostic platforms. We are a biomarker and diagnostic content provider that strengthens diagnostics for everyone. Through our approach of innovation, clinical evidence and global CDMO partnerships, we ensure that next-generation biomarkers are accessible across diagnostic platforms, so patients benefit no matter which system is used.

Position Summary:

The individual will assist in the management and development of new immunoassay manufacturing processes which include creating SOPs/batch records, executing in-process test methods for raw material Critical Quality Attributes, demonstrating process robustness and scalability, and facilitating new process transfer to the manufacturing environment. Other responsibilities will include designing, planning and executing experiments in a GMP/GLP environment, interpreting results and summarizing data into project reports, and performing the necessary tasks to complete a Design Control project.

Essential Job Functions:

• Performs a major role in the initiation of development projects with technical focus on leading process concept characterization and feasibility lot builds.
• Performs a major role in the generation, summary, and transfer of manufacturing process information for the initiation of Design Control projects.
• Establishes Manufacturing processes and Quality Control (QC) procedures for new products.
• Executes the necessary reagent (microparticle/conjugate), calibrator and or control builds of Verification lots to support Design Verification activities.
• Performs and/or supports Process Validation studies to support Process transfer into Manufacturing.
• Performs and/or supports the scale-up of new manufacturing processes as needed.
• Responsible for the transfer of new technologies, products and/or manufacturing processes internally and/or externally.
• Manages the training of Manufacturing operators, QC technicians, and Quality Assurance (QA) personnel in specific areas of expertise.
• 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):

• Strong knowledge of assay standardization and calibrator/control manufacturing process
• Strong 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 skill
• Must be detail-oriented and thorough
• Ability to work with various software packages
• Ability to make presentations to various groups of individuals
• Ability to travel nationally and internationally
• Ability to work with potentially hazardous materials
• Manual dexterity and ability to do visual inspections
• Protein modification/chemistry knowledge desirable

Education and Work Experience Required:

• B.S. or M.S. in Science/Engineering
• Previous laboratory experience in the diagnostic or pharmaceutical industries

The base salary range for this position is $76,000- $88,000/year. The actual base pay offered may vary depending on multiple factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. The typical work schedule for this position is Monday to Thursday with half-day Fridays.

We offer a competitive benefits package that starts on day one, including three medical plans, savings and spending accounts, employer-paid dental & vision, 401(k) match up to 6%, life insurance and disability, educational assistance, EAP, generous Paid Time-Off, paid holidays, and opportunity for advancement.

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