KBI: US - Principal Scientist

KBI Biopharma•Durham, NC

4d•Onsite

About The Position

KBI Biopharma is seeking a highly skilled and motivated Senior Level Analytical Scientist to join our Analytical and Formulation Sciences (AFS) team in Durham, NC. This role is ideal for an experienced scientist with deep expertise in protein analytics. You will serve as a subject matter expert (SME), driving innovation and excellence in analytical testing to support integrated and standalone client programs from early development through commercialization. This position collaborates cross-functionally with process development, analytical development, characterization, and regulatory teams.

Requirements

Ph.D. in Biophysics, Biochemistry, Analytical Chemistry, Biochemical Engineering and 8+ years of experience or Masters and 10+ years of experience or Bachelors or 12+ years of experience.
Able to react to change and handle other essential tasks as assigned.
Adhere to all safety requirements and assure that departmental employees comply with required safety procedures.
Excellent communication skills and ability to present complex data to diverse audiences.
Proficiency in scientific software and data analysis tools.
Ability to work independently and collaboratively in a fast-paced environment.

Responsibilities

Design and strategically execute analytical experiments in support of cGMP testing.
Demonstrate expertise in HPLC/UPLC, ELISA, icIEF and other common analytical techniques.
Design and implement analytical strategies to support product development and regulatory submissions.
Generate high-quality documentation suitable for publication and regulatory review.
Act as SME on client programs, providing technical guidance and representing KBI in client interactions.
Mentor and train junior scientists and associates.
Perform peer reviews of data and reports related to method development, qualification, and validation.
Manage timelines and resources to meet project milestones.
Advise leadership on program status and technical challenges.
Contribute to continuous improvement initiatives within the AFS team.