Scientist I

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

Job summary

KBI Biopharma in Durham, NC seeks a highly skilled Analytical Scientist to join the Analytical and Formulation Sciences team. PhD-level expertise in protein analytics with a background in formulation development and analytical methods development and qualification is ideal.

You will drive innovation and support biotherapeutics programs from development through commercialization. Responsibilities include developing and validating analytical methods, interpreting complex data, mentoring junior

Qualifications

• PhD-level expertise in protein analytics and formulation development preferred.
• Experience with analytical methods development and qualification/validation.

Responsibilities

• Execute and interpret experiments to meet project goals (HPLC/UPLC, CGMP/quality control).
• Serve as SME for analytical methods and troubleshooting.
• Design analytical experiments for formulation, method development, and stability programs.
• Support regulatory submissions with analytical strategy and documentation.
• Mentor junior scientists and coordinate cross-functional collaboration.
• Manage project timelines and resources to meet milestones.

Skills

Protein analytics

Data analysis tools

Scientific communication

Independent & collaborative

CGMP/GDP knowledge

Education

PhD in Biophysics/ Biochemistry/ Analytical Chemistry/ Biochemical Engineering

MS with 5 years of related experience

BS with 7 years of related experience

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. 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 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

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.