Data Reviewer/ Senior Scientist #514 Job at KBI Biopharma in
Durham, NC Job Summary:
Perform data review for contract services projects, including
analytical and formulations programs for monoclonal antibodies,
recombinant proteins, peptides, and small molecules in a variety of
dosage form such as liquids and lyophilized powders and suspensions
for injection, topical gels, and other novel delivery systems.
Job Description: Perform timely review of cGMP data from HPLC,
ELISA, CE, etc. with a high focus on data quality and integrity to
ensure accuracy, completeness, and compliance.
Verify that calculations and documented information are present,
complete and accurate.
Verify that all analysis performed is per methodology and is in
compliance with GMP requirements.
Maintains and updates knowledge of instrumentation.
Maintains familiarity and professional expertise through
familiarity with scientific literature.
Responsible for developing/maintaining a current understanding
of cGMP and other regulatory requirements.
Able to react to change productively and handle other essential
tasks as assigned.
Job Requirements: B.A. or B.S. degree in chemistry, biochemistry
or related area (or equivalent training) with 7+
years' experience, or MS and up to 5+ years’ experience.
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 Vietnam
veteran status, are strongly encouraged to apply.