Senior Research Associate

KBI Biopharma•Durham, NC

1d•$65,000 - $85,000•Onsite

About The Position

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: Join a highly technical analytical team in a dynamic work environment. Participate in contracted client analytical programs as a member of Analytical and Formulation Sciences (AFS) team. Perform testing services including GMP testing, analytical method transfer activities, analytical method qualification/validation activities with a focus on separations technologies (HPLC, UPLC, western blot, SDS-PAGE, CE-SDS). Abilities in other analytical techniques applicable to the business needs are desirable (Biophysical methods, ELISA, qPCR, etc).

Requirements

Bachelor’s degree in chemistry, biochemistry, or related area (or equivalent training) with 4+ years of experience or Master’s degree with 2+ years of experience.
Able to react to change productively and handle other essential tasks as assigned.
Good oral presentation and technical writing skills are required.
Records (accurately, clearly, and consistently) information, facts, and measurements that are required by cGMP, GLP, GCP, and/or by co-workers to understand situations and to perform their assignments.
Understanding of biotherapeutic regulatory requirements and expectations.
Strong communication and organizational skills.

Nice To Haves

Experience in chromatographic, electrophoretic, and immunoassay analytical techniques are preferred.
Abilities in other analytical techniques applicable to the business needs are desirable (Biophysical methods, ELISA, qPCR, etc).

Responsibilities

Execute testing for GMP testing including product release and stability, analytical method transfer, analytical method qualification/validation activities as instructed by controlled documents.
Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals
Review and analyze data for the experiments performed by self and by other analysts.
Responsible for producing high quality documentation, client reports, etc. suitable for publication and regulatory requirements.
Makes detailed observations and carries out elementary data analysis.
Maintains documentation and writing skills.
Understand experiments and conducts troubleshooting analysis
Responsible for maintaining a current understanding of cGMP and other regulatory requirements.
Maintains familiarity with current scientific literature, maintains professional expertise through familiarity with scientific literature.
Maintains and updates knowledge of instrumentation.
React to change productively and handle other essential tasks as assigned.