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USA - NC - Durham - Emperor Blvd, United States of America
Onsite
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. Must have 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 (but not limited to) HPLC, SDS-PAGE, SDS-CGE, ELISA, UV-Vis, and/or biophysical characterization techniques. Review of Logbooks and simple assays without calculations such as (but not limited to) solution logbooks, pH, osmolality, color, clarity.
Make detail 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.
Reacts to change productively and handles 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
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.