Development Scientist

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

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 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 desirableExcellent 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
• Ability to travel nationally and internationally

Education and Work Experience Required

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

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