Development Scientist II.

POSITION DESCRIPTION:  Responsible for providing specific scientific, technical and compliance support of assigned projects within Immunodiagnostic product development team. Maintains broad knowledge of state-of-the-art principles and theories.  Makes major contributions to scientific literature and conferences.  Serves as an in-house consultant and advise management on scientific decisions.  May act as spokesperson on corporate research and development.  Interfaces with various departments.  Uses professional concepts and relationships to contribute to the development and completion of company goals and objectives in creative and effective ways.Scale-up, design verification and transfer of immunodiagnostic products and processes into cGMP compliant manufacturing environment.  Development and validation of methods supporting product manufactureDesign and execution of studies to show product robustness and manufacturabilityCreation of all necessary documentation, including manufacturing specifications, QC test procedures, raw material specifications and validation protocols.Excellent assay skillsKnowledge of experimental designKnowledge of product development studies, study protocols and related reportsExperience in a GMP facilityStrong leadership, verbal and written communication, organizational and team skill

? Has ability to work as an independent investigator.

? Investigates the feasibility of applying scientific principles and concepts to potential inventions, products, laboratory services, and problems.

? Independently plans and executes laboratory experimentation.

? Maintains broad knowledge of state-of-the-art principles and theories. Makes major contributions to scientific literature and conferences.

? May act as in-house consultant and advise management on scientific decisions.

? Interfaces with various departments.

? Uses professional concepts and relationships to contribute to the development and completion of company goals and objectives in creative and effective ways.

? May direct 1?3 technicians.

 

EDUCATION/EXPERIENCE:  Requires a Ph.D. in a scientific discipline or equivalent and a minimum of 2 to 5-year experience in a research and/or development environment.  Non-Ph.D. candidates who have demonstrated exceptional capabilities and a minimum of 5 to 8-year experience in a research and/or development environment will be considered.  Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.  Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.  Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.  Expert knowledge of scientific principles and concepts.  Normally receives no instructions on routine work and general instructions on new assignments.