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.
- 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.
- B.A. or B.S. degree in chemistry, biochemistry or related area (or equivalent training) with 2+ years’ experience, or MS and up to 0+ years’ experience. Senior Research Associate requires degree as described and 5+ years’ experience (or MS and 2+ 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.
Qualified candidates, please email your resume to email@example.com