Principal Development Scientist

Job Description

Fujirebio Diagnostics, Inc., located in Malvern, PA, is a world leader in the production of
in-vitro diagnostics, setting the worldwide gold standard for the manufacturing in biomarkers.

We have an immediate opening for a Principal Development Scientist. The Principal Development Scientist is responsible for immunoassay products. This includes the necessary tasks to complete the project/product feasibility, optimization and preparation of a product for entry into Design Control. The individual will also have input for the Design Verification of new products and/or products undergoing Design Changes. Other responsibilities include providing technical guidance on scientific projects and managing and planning experiments in a GMP/GLP environment and interpreting scientific results.

Essential Functions include:

Provides technical guidance on the research and development of immunoassays on automated or manual platforms

Designs feasibility, optimization and/or Design Verification studies to support device development

Manages the transfer of new technologies, products and/or manufacturing processes into and out of the company

Participates in the investigation of new technologies and novel biomarkers

Prepares technical reports and cost estimates

Summarizes data, documents development work, and recommends conclusions based on scientific rationale

Supports the design, execution and evaluation of experimental plans to ascertain the required process capabilities, specifications and robustness

Follows all company environmental, health and safety policies, procedures and guidelines and conducts work in a safe manner

Responsible for providing an environment which encourages the company's commitment to equal employment opportunity and the value of a diverse work force.
Other duties as assigned.

Qualified candidate will have degree in the Biological Sciences, Masters or PhD preferred; 7 plus years of laboratory experience in the diagnostic or pharmaceutical industries; 5 plus years of management experience; knowledge and hands-on experience in immunoassay development, project management, design control , antibody selection and optimization for automated immunoassays; ability to write clear, concise technical reports; strong analytical disposition, mathematical reasoning skills and decision-making aptitude; strong attention to detail is essential; excellent verbal and written communication skills; must be detail-oriented and thorough; ability to work with various software packages; ability to make clear and concise technical presentations to various groups of individuals and respond to technical questions; proficient knowledge of FDA regulatory requirements and a broad knowledge of relevant governmental regulations; ability to interact effectively with people to establish and maintain excellent working relationship with all organizational levels; ability to plan and prioritize multiple complex activities simultaneously; ability to work irregular hours, weekends and holidays when necessary; ability to analyze date detecting inconsistencies, determining relative importance and to solve complex technical situations based on data.

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/Affirmative Action employer. Women, minorities, persons with disabilities and veterans are encouraged to apply


Fujirebio Diagnostics

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