Analytical Scientist - GMP Method Validation

KBI Biopharma, Inc.; Durham (NC); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental, and vision coverage

Paid PTO & holidays

401K matching

Employee recognition programs

Job summary

KBI Biopharma, Inc. seeks a qualified analytical scientist to join the Analytical and Formulation Sciences team on contracted client programs. You will perform GMP testing, support method transfer, qualification and validation activities focused on separations technologies like HPLC/UPLC.

Additional techniques such as ELISA or qPCR are a plus. The role emphasizes producing high-quality data and documentation suitable for regulatory submissions, with adherence to cGMP and GLP requirements.

Qualifications

• Requires Bachelor's degree in chemistry, biochemistry, or related area (or equivalent training) with 5+ years of experience or Master's degree with 3+ years of experience.
• Good oral presentation and technical writing skills are required.
• Records (accurately, clearly, and consistently) information, facts, and measurements that are required by cGMP, GLP, GCP, and/or by co-workers to understand situations and to perform their assignments.
• Understanding of biotherapeutic regulatory requirements and expectations.
• Experience in chromatographic, electrophoretic, and immunoassay analytical techniques are preferred.
• Strong communication and organizational skills.

Responsibilities

• Execute testing for GMP testing including product release and stability, analytical method transfer, analytical method qualification/validation activities as instructed by controlled documents.
• Review and analyze data for the experiments performed by self and by other analysts.
• Responsible for producing high quality documentation, client reports, etc. suitable for publication and regulatory requirements.
• Understand experiments and conducts troubleshooting analysis.
• Responsible for maintaining a current understanding of cGMP and other regulatory requirements.
• Maintains familiarity with current scientific literature, maintains professional expertise through familiarity with scientific literature.
• Maintains and updates knowledge of instrumentation.

Skills

GMP testing

Analytical methods

Data analysis

Technical writing

Communication

Education

Bachelor's degree in chemistry/biochemistry or related field

Tools

HPLC

UPLC

Western blot

SDS-PAGE

CE-SDS

ELISA

qPCR

Job description

KBI Biopharma, Inc. seeks a qualified analytical scientist to join the Analytical and Formulation Sciences team on contracted client programs. You will perform GMP testing, support method transfer, qualification and validation activities focused on separations technologies like HPLC/UPLC.

Additional techniques such as ELISA or qPCR are a plus. The role emphasizes producing high-quality data and documentation suitable for regulatory submissions, with adherence to cGMP and GLP requirements.