GMP Analytical Scientist: HPLC, Validation & Reporting

KBI Biopharma, Inc.; Durham (NC); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Medical coverage

Dental coverage

Vision coverage

Paid PTO and holidays

401K matching

Employee recognition programs

Job summary

KBI Biopharma, Inc. is seeking a skilled scientist to join its Analytical and Formulation Sciences team in Durham, NC. You will perform GMP testing for product release and stability, and contribute to method transfers, qualifications, and validations using HPLC/UPLC and related techniques.

The role requires strong data analysis, documentation, and communication skills, with familiarity in cGMP and regulatory expectations. Join a global CDMO committed to quality and innovation.

Qualifications

• Requires Bachelor’s degree in chemistry, biochemistry, or related area with 4+ years of experience or Master’s degree with 2+ years of experience.
• Strong oral presentation and technical writing skills are required.
• Understanding of biotherapeutic regulatory requirements and expectations.

Responsibilities

• Execute GMP testing including product release and stability.
• Perform analytical method transfer/qualification/validation activities.
• Review and analyze data; prepare high-quality documentation and client reports.
• Maintain instrument knowledge and troubleshoot experiments.
• Ensure compliance with cGMP and regulatory requirements.

Skills

HPLC/UPLC

Western blot

SDS-PAGE

qPCR

Data analysis

Technical writing

gCMP/regulatory awareness

Chromatography

Education

Bachelor’s degree in chemistry/biochemistry or related

Master’s degree (optional)

Tools

Analytical instruments knowledge

Job description

KBI Biopharma, Inc. is seeking a skilled scientist to join its Analytical and Formulation Sciences team in Durham, NC. You will perform GMP testing for product release and stability, and contribute to method transfers, qualifications, and validations using HPLC/UPLC and related techniques.

The role requires strong data analysis, documentation, and communication skills, with familiarity in cGMP and regulatory expectations. Join a global CDMO committed to quality and innovation.