Immunoassay Development Scientist

Position Summary: The individual will assist in all aspects during the development of immunoassays, up to and including performing product feasibility tasks and supporting the necessary tasks to complete a Design Control project.

Responsibilities will include designing, planning and executing experiments in a GMP/GLP environment, interpreting results and summarizing data into project reports.

 

Essential Job Functions:


* Performs a major role in the initiation of development projects with technical focus on leading proof of concept and feasibility studies.


* 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 and/or supports the necessary Design Verification studies to support new product launches.


* Performs and/or supports Design Validation studies to support new product launches.


* Performs and/or supports the scale-up of new manufacturing processes as needed.


* Supports the transfer of new technologies, products and/or manufacturing processes into and out of the company.


* Trains analytical development scientists, clinical personnel, and quality control technicians in specific areas of expertise.


* Serves as the subject matter expert member on risk assessment, investigation, and audit support teams, as needed.


* 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):


* B.S.

or M.S.

in Science/Engineering


* Minimum of 5 years of laboratory experience in the diagnostic or pharmaceutical industries


* Strong immunoassay development and manufacturing experience


* Strong technical problem-solving skills and discipline


* Strong organizational and time management skills desirable


* 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 lead technical project teams


* 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

 

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