Senior Analytical Scientist: GMP Method Validation & HPLC Expert

KBI Biopharma, Inc.; North Carolina; On-site; USD 65,000 - 85,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a skilled analytical scientist to work within the Analytical and Formulation Sciences team in a highly technical environment. You will perform GMP testing, method transfer/validation activities, and contribute to client programs.

The role emphasizes data analysis, documentation quality, and adherence to cGMP and regulatory expectations. Strong communication and writing skills are essential, with opportunities in a global CDMO setting.

Qualifications

• Requires a bachelor’s degree in chemistry, biochemistry, or related field with 4+ years of experience or a master’s degree with 2+ years of experience.
• Proficient in oral presentation and technical writing; able to document clearly and accurately.

Responsibilities

• Execute GMP testing including product release and stability and analytical method transfer/qualification/validation activities as instructed.
• Review and analyze data for experiments performed by self and others.
• Produce high-quality documentation and client reports suitable for publication and regulatory requirements.
• Make detailed observations and perform elementary data analysis; maintain documentation and writing skills.
• Understand experiments and perform troubleshooting analyses.
• Maintain current understanding of cGMP and other regulatory requirements.
• Stay up-to-date with scientific literature and instrument knowledge; adapt to changes and other essential tasks.

Skills

Strong communication

Organizational skills

Oral presentation

Technical writing

Education

Bachelor's degree in chemistry/biochemistry related area

Master’s degree (optional)

Job description

KBI Biopharma, Inc. is seeking a skilled analytical scientist to work within the Analytical and Formulation Sciences team in a highly technical environment. You will perform GMP testing, method transfer/validation activities, and contribute to client programs.

The role emphasizes data analysis, documentation quality, and adherence to cGMP and regulatory expectations. Strong communication and writing skills are essential, with opportunities in a global CDMO setting.