Data Reviewer/Scientist I

KBI Biopharma • Durham, NC

55d • $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: Perform data review for contract services projects, including GMP testing for internal and external manufacturing and stability studies, as well as analytical and formulation development programs for monoclonal antibodies, proteins, and peptides.

Requirements

• 3 years of experience following cGMP documentation practices.
• 3 years of experience working with formulas, scientific equations, and graphs; 3 years of experience in analytical software, including Empower , SoftMax, or Compass.
• 3 years of experience with GMP testing, stability studies, analytical and formulation development of monoclonal antibodies, proteins, or peptides.
• 3 years of experience within a pharmaceutical setting completing weekly analytical data review assignments in cGMP environment and independently handling Method Qualification and Method Validation reviews.
• 3 years of experience with Biopharmaceutical regulatory agency (FDA/EMA) inspection readiness for data integrity ALCOA+ and 21 CFR part 11 regulatory compliance requirements in cGMP environment.

Responsibilities

• Data review for assay categories: Particle Analysis, Spectrophotometry, Gel Analysis, Plate Based Assay, Binding Assay, HPLC, Trace Analysis, Capillary Electrophoresis, Biophysical Techniques, Method Qualification and Validation.
• Maintain knowledge of instrumentation and GMP standards
• Employ data review software (Empower, 32 Karat, Softmax, Compass, Chemidoc).
• Verify that calculations, electronic data, and documented information are compliant and accurate.
• Make detailed observations and report documentation corrections as needed.
• Demonstrate strong communication and ability to work independently and as part of a team.

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 upon hire and employee recognition programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: No Education Listed
• Number of Employees: 1,001-5,000 employees