Scientist I

KBI Biopharma•Durham, NC

7d•Onsite

About The Position

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.

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.

Nice To Haves

Deep expertise in protein analytics
Background in formulation development
Background in analytical methods development and qualification

Responsibilities

Demonstrates expertise in the execution and interpretation of experiments that contribute to project goals.
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.