SENIOR SCIENTIST BIOLOGIST in ALLENTOWN, PA

Leading R&D Oral Fluid Diagnostics Company looking for a Senior Scientist

*Responsible for the design and generation of reagents and raw materials used in the development of in-vitro diagnostic assays.**
Conduct research to find replacements for existing products.
Develop formulation processes for transfer to cGMP manufacturing. Verify processes & develop test methods according to spec.Investigate by experimentation to identify parameters that are critical to quality.Design and execute validation of test methods and processes. Identify and develop new materials to incorporate into product.Responsibilities:
Design experiments, analyze data and draw conclusions.Generate study reports and design control documentation.Conduct feasibility evaluation of new raw materials.Optimize formulations & product methods for immunoassay components.Verify new production methods and formulations.Write SOPs, Batch Production Records and other documents.Generate/execute validation protocols for new processes.Troubleshoot current products as part of an inter-departmental product support team.Generate new antibodies and antigens for immunoassay development with outside vendors.Follow the quality system and regulatory requirements.May participate in cross-functional product development teams.Contribute technical instruction and supervision of others.Qualifications
Prepare protein/peptide & antibody conjugates for immunoassays.Know analytical techniques to prepare/analyze immunoassay components.Proficient in basic protein chemistry/protein modification and methods required for protein analysis.Design of Experiments (DOEs), formulation and process latitude studies and process verification.Previous experience in the development/optimization of detection systems based on colloidal particles is preferred.Experience in product development in a medical diagnostics field is preferred.Strong orientation to laboratory work with demonstrable communication skills, both written and oral.Experience with laboratory tools, instruments, and procedures. Demonstrated computer skills for data analysis and report writing.Education
PhD in Biology, Biochemistry, Immunology or related field-OR- 10+ years experienceOur recruiters are actively reviewing resumes received through the online application process. To be considered for this position, as well as future positions, please click the Apply Now button, and submit your resume.




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