Scientist I

KBI Biopharma, Inc.; Durham (NC); On-site; USD 84,000 - 115,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an Analytical Scientist to join the Analytical and Formulation Sciences team in Durham, NC.

This role targets a PhD-level scientist with deep protein analytics experience to drive innovation and analytical testing for client programs from early development through late-stage and commercialization for biotherapeutics. The position emphasizes method development, qualification/validation, formulation strategies, and collaboration with cross-functional teams to ensure

Qualifications

• PhD or MS with required years of experience as listed in the posting.
• Expertise in protein analytics and analytical method development.
• Familiar with CGMP and GDP practices; strong data presentation skills.

Responsibilities

• Execute and interpret experiments contributing to project goals.
• Serve as SME for analytical methods and troubleshooting.
• Design analytical experiments for formulation, method development, qualification/validation and stability programs.
• Develop strategies to support product development and regulatory submissions.
• Generate high-quality documentation for publication and regulatory review.
• Collaborate with cross-functional teams including process development, manufacturing, QA and program management.
• Mentor junior scientists and review data and reports.

Skills

HPLC/UPLC

Capillary Electrophoresis

UV/Fluorescence

Biophysical characterization

Protein analytics

Education

PhD in Biophysics/Biochemistry/Analytical Chemistry/Biochemical Engineering

MS with 5 years related experience

BS with 7 years related experience

Tools

SDS-CGE/ icIEF

CGMP knowledge

Data analysis software

Job description

KBI Biopharma is seeking a highly skilled and motivated Analytical Scientist to join our Analytical and Formulation Sciences (AFS) team in Durham, NC. The 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 execution and interpretation of experiments that contribute to project goals.
• Techniques 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.
• Serves as SME for several methods to support advanced troubleshooting analysis.
• Designs and strategically executes analytical experiments in support of biotherapeutics development such as formulation, analytical methods development and qualification/validation, and stability programs.
• Designs and implements analytical strategies to support product development and regulatory submissions.
• Generates high-quality documentation suitable for publication and regulatory review.
• Acts as SME on client programs, providing technical guidance and representing KBI in client interactions.
• Collaborates cross‑functionally with process development, manufacturing, program management, data review, and quality assurance teams.
• Mentors and trains junior scientists and associates.
• Performs peer reviews of data and reports related to method development, qualification, and validation, as well as material characterization and stability study reports.
• Manages timelines and resources to meet project milestones and proactively advises 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.
• Adheres to all safety requirements and ensures 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

EEO Statement

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.