KBI Biopharma is seeking a highly skilled and motivated Analytical Scientist to join our Analytical and Formulation Sciences (AFS) team in Durham, NC. This role is ideal for a PhD-level scientist with deep expertise in protein analytics, ideally with a background in formulation development and analytical methods development and qualification. You will serve as a subject matter expert (SME), driving innovation and excellence in analytical testing to support client programs from early development through late-phase  and commercialization for biotherapeutics.

Position Responsibilities:

• Demonstrates expertise in the execution and interpretation of experiments that contribute to project goals. Techniques to applied may include HPLC/UPLC, Capillary Electrophoresis (SDS-CGE and icIEF), UV/Fluorescence, compendial methods, and biophysical characterization techniques on proteins (CD, FTIR, DLS, SEC-MALS, calorimetry) to monitor physical and chemical stability of proteins.
• Serve as an SME for several methods to support advanced troubleshooting analysis.
• Design and strategically execute analytical experiments in support of biotherapeutics development such as formulation, analytical methods development and qualification/validation, and stability programs
• 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.
• Collaborate cross-functionally with process development, manufacturing, program management, data review, and quality assurance teams.
• Mentor and train junior scientists and associates.
• Perform peer reviews of data and reports related to method development, qualification, and validation, as well as material characterization and stability study reports.
• Manage timelines and resources to meet project milestones and proactively advise leadership on program status and technical challenges.

Minimum Requirements:

• Ph.D. in Biophysics, Biochemistry, Analytical Chemistry, Biochemical Engineering; an M.S. degree and 5 years of related experience; or a B.S. degree and 7 years of related experience.
• Able to react to change and handle other essential tasks as assigned. Adhere to all safety requirements and ensure that departmental employees comply with required safety procedures.
• Strong understanding of protein structure and stability, degradation pathways and aggregation and higher-order structure analysis.
• 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.
• Working knowledge of CGMP and GDP practices.

Salary:

$84,000-$115,000