KBI: US - Data Reviewer/Senior Research Associate

KBI Biopharma•Durham, NC

4d•$63,000 - $86,900

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: This is a Data Reviewer position in Analytical and Formulation Sciences department reporting to Project Leader. Responsibilities: Perform data review for contract services projects, including GMP testing for internal and external manufacturing and stability studies, analytical and formulation development for monoclonal antibodies, recombinant proteins and peptides. Follow manager’s instructions to complete job responsibilities and spend approximately 95% time on data review for assay categories as outlined in Job Responsibility section. Understand principles of the technologies in scope for data review at respective job title level. Verify that calculations and documented information are correct, complete and accurate in accordance with guiding documents and internal procedures. Maintain and update knowledge of relevant instrumentation and cGMP standards. 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. Data reviewer job responsibilities and approximate percent of time are allocated based on the assay complexity level are: 1. Logbooks and simple assays without calculations Instrument or Solution Logbooks, Appearance, Color, Clarity, Turbidity, pH, Osmolality, particle analysis KF, Viscosity, HIAC, MFI - 20% 2. Spectrophotometric assays UV, SoloVPE, Gel analysis SDS-PAGE, Western Blot, IEF, ELISA, BCA - 75% 3. Maintain and update knowledge of technologies and cGMP standards 5%

Requirements

Must have background in biopharmaceutical analytical testing, understand cGMP standards.
Demonstrate strong communication and interpersonal skills.
BS/BA with minimum 4 years of related experience or MS/MA with minimum 2years of related experience.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, percent, molarity and other common calculations used in biochemistry.
Ability to generate and interpret graphs and plots.

Responsibilities

Perform data review for contract services projects, including GMP testing for internal and external manufacturing and stability studies, analytical and formulation development for monoclonal antibodies, recombinant proteins and peptides.
Follow manager’s instructions to complete job responsibilities and spend approximately 95% time on data review for assay categories as outlined in Job Responsibility section.
Understand principles of the technologies in scope for data review at respective job title level.
Verify that calculations and documented information are correct, complete and accurate in accordance with guiding documents and internal procedures.
Maintain and update knowledge of relevant instrumentation and cGMP standards.
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.
Logbooks and simple assays without calculations Instrument or Solution Logbooks, Appearance, Color, Clarity, Turbidity, pH, Osmolality, particle analysis KF, Viscosity, HIAC, MFI - 20%
Spectrophotometric assays UV, SoloVPE, Gel analysis SDS-PAGE, Western Blot, IEF, ELISA, BCA - 75%
Maintain and update knowledge of technologies and cGMP standards 5%