Senior Research Associate/Data Reviewer

Position Summary Join a highly technical analytical team in a dynamic work environment where you will participate in contracted client analytical programs as a member of the Analytical, Formulation and Stability (AFS) Department. This role is responsible to perform data review for contract services projects, including nonGMP testing for internal and external process development studies, analytical and formulation development for monoclonal antibodies, recombinant proteins and peptides. Collaborate with supervisor to complete job responsibilities and spend approximately 95% time on data review for assay categories as outlined in Job Responsibility section listed below. Position Responsibilities Thorough understanding of principles of the technologies in scope for data review. Verify that calculations and documented information are correct, complete and accurate in accordance with guiding documents and internal procedures. Background in biopharmaceutical analytical testing; understanding cGMP standards is recommended. Knowledge of drug substance/drug product or formulation samples using bio-analytical techniques such as HPLC, SDS-PAGE, SDS-CGE, ELISA, UV-Vis, and/or biophysical characterization techniques. Review of Logbooks and simple assays without calculations such as solution logbooks, pH, osmolality, color, clarity. Make detailed observations and report documentation corrections required to analysts and their managers, as needed. Contribute to review related feedback, including review group needs, to the functional management. Work with functional management to improve review cycle time. Review of data summary reports and technical documents. Maintain and update knowledge of relevant instrumentation. Demonstrate good communication and interpersonal skills. React to change productively and handle other essential tasks as assigned. Minimum Requirements Senior Research Associate: B.A or B.S. degree in chemistry, biochemistry or related area (or equivalent training) and 3-5 years of experience or a Master's degree with minimum of 2 years of experience. Salary $63,000-$86,000 EEO Statement KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. #J-18808-Ljbffr KBI Biopharma, Inc.