KBI Biopharma · 18 hours ago
Data Reviewer/Associate Scientist
Durham, NC
Full-time
Onsite
Mid Level
$78K/yr - $95K/yr
3+ years expKBI Biopharma is a global leader in biopharmaceutical development and manufacturing, empowering life science companies to bring new medicines and vaccines to the world faster. The Data Reviewer/Associate Scientist will perform data reviews for various analytical and formulation projects, ensuring compliance with GMP standards and contributing to the improvement of review processes.
BiopharmaBiotechnologyHealth CareManufacturing
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:
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%
Qualification
Required
Must have background in biopharmaceutical analytical testing, understand cGMP standards
Demonstrate strong communication and interpersonal skills
BS/BA with minimum 5 years of related experience or MS/MA with minimum 3 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
Benefits
Annual bonus structure for all employees
Medical, dental, and vision coverage
Paid PTO and holidays
401K matching with 100% vesting in 60 days
Employee recognition programs
Company
KBI Biopharma
KBI Biopharma, Inc. (KBI) is a leading development and contract manufacturing organization serving the biopharmaceutical industry. We help
1001-5000 employees
H1B Sponsorship
KBI Biopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (11)
2023 (18)
2022 (26)
2021 (14)
2020 (21)
Funding
Current Stage
Late StageTotal Funding
$109.47MKey Investors
JSR
2025-10-01Corporate Round· $99.87M
2016-12-08Series Unknown
2009-09-22Series Unknown· $9.6M
Leadership Team
Peter Carbone
Chief Operating Officer
Sigma Mostafa
Chief Scientific Officer
Recent News
Kalaris Therapeutics, Inc.
2025-11-14
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