Senior Analytical Scientist – GMP Methods & Validation

KBI Biopharma; Durham (NC); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Annual bonus structure

Medical, dental, and vision coverage

Paid PTO and holidays

401K matching with vesting

Job summary

KBI Biopharma in Durham, NC, is seeking a highly skilled analytical professional to join the Analytical and Formulation Sciences team. You will perform GMP testing for product release and stability, support analytical method transfer and qualification activities, and review data with strong documentation practices.

The role requires advanced technical writing and presentation skills, with familiarity in cGMP and regulatory expectations.

Qualifications

• Requires Bachelor’s degree in chemistry, biochemistry, or related area with 5+ years of experience or Master’s degree with 3+ years of experience.
• Good oral presentation and technical writing skills are required.
• Records information clearly and consistently per cGMP/GLP/GCP requirements.
• Understanding of biotherapeutic regulatory requirements.
• Experience in chromatographic, electrophoretic, and immunoassay techniques preferred.

Responsibilities

• Execute GMP testing including product release and stability, method transfer and qualification/validation per documents.
• Review and analyze data for experiments performed by self and others.
• Produce high-quality documentation and client reports suitable for publication and regulatory requirements.
• Understand experiments and conduct troubleshooting analysis.
• Maintain current understanding of cGMP and regulatory requirements.
• Stay updated with literature and instrumentation knowledge; adapt to change.
• React to change productively and handle other essential tasks as assigned.

Skills

GMP testing

Method transfer

Tech writing

Oral presentation

Documentation

Communication

Education

Bachelor’s degree in chemistry/biochemistry

Master’s degree in related field

Tools

HPLC

UPLC

Western blot

SDS-PAGE

CE-SDS

qPCR

ELISA

Job description

KBI Biopharma in Durham, NC, is seeking a highly skilled analytical professional to join the Analytical and Formulation Sciences team. You will perform GMP testing for product release and stability, support analytical method transfer and qualification activities, and review data with strong documentation practices.

The role requires advanced technical writing and presentation skills, with familiarity in cGMP and regulatory expectations.