Job Title: Research Scientist
Pay Rate: $37 - 45/HR
Location: Durham, NC
ZIP Code: 27713
Start Date: Right Away
Shift: 1st shift; M-F 8:30am-4:30pm
Responsibilities:
* Responsible for leading efforts to develop, qualify, validate and implement analytical methods (Biochemical, Immunological, Enzymatics and cell-based Methodology) necessary to support all phases of Drug development projects.
* Responsible for characterizing process intermediates and drug products for current and novel biotherapeutics
* Analyze, interpret data (including troubleshooting) and relationships in data across different analytical techniques.
* Work effectively under general supervision and contribute to team efforts to support CMC Development projects.
* Effectively communicates functional area and departmental technical data in cross-functional settings.
* Must be a subject matter expert in the development, validation and implementation of immunoassay and analytical software for non-linear regression models (e.g. 4 and 5 parameter logistic models).
* Must have considerable knowledge in professional field of specialization, including the awareness and application of applicable regulatory guidance documents.
* Independently applies sound scientific principles in development of innovative solutions to complex technical problems.
* Maintains laboratory facilities in accordance with company policies and industrial best practices.
Requirements:
* Bachelor's degree and 6+ years related experience OR
* Master's degree and 3+ years related experience OR
* PHD and 2+ years related experience
* Experience using modern instrumental analytical techniques, including plate reader, pH meter, balance, making solutions, single and multi-channel pipetting.
* Experience in designing quantitative methods and method qualification/ validation.
* Experience with protein analytical techniques such as enzymatic assays (e.g. coagulation), cell-based assays, gel electrophoresis, and Western blotting is a plus.
* Experience working in a regulated environment and proficiency with statistical software such as SAS JMP is a plus.
Assay Development (Protein and Cell-based, including blood/tissue culturing) Western Blotting with SDS-PAGE, Gel electrophoresis(Not DNA/RNA or PCR), ELISA, Cell-Based (Flowcytometry/FACS)
