Senior Research Associate/Data Reviewer

KBI Biopharma • Durham, NC

4d

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• understanding cGMP standards is recommended

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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior