Data Reviewer/Scientist I

KBI Biopharma • Durham, NC

1d • $84,000 - $105,000

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 position performs 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.

Requirements

• Must have background in biopharmaceutical analytical testing, understand cGMP standards.
• Demonstrate strong communication and interpersonal skills.
• BS/BA with minimum 6 years of related experience or MS/MA with minimum 4 years 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

• The individual in this position will spend approximately 90% of their work time performing data review for assay categories as outlined in Job Responsibility section.
• Logbooks and simple assays without calculations Instrument or Solution Logbooks, Appearance, Color, Clarity, Turbidity, pH, Osmolality, particle analysis KF, Viscosity, HIAC, MFI Spectrophotometric assays UV, SoloVPE, Gel analysis SDS-PAGE, Western Blot, IEF, ELISA, BCA HPLC, plate-based assays, Capillary Electrophoresis, biophysical techniques
• Maintain and update knowledge of technologies and cGMP standards
• The Data Reviewer/Scientist I must understand 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, maintain and update knowledge of relevant instrumentation and cGMP standards.
• The Data Reviewer/Scientist I will make detailed observations and report required documentation corrections to analysts and their managers, as needed.
• This role will contribute to review-related feedback, including review group needs, to the functional management and will work with functional management to improve review cycle time.

Benefits

• KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees