Scientist I

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

Job summary

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

This role targets PhD-level scientists with deep protein analytics experience and a background in formulation development and analytical methods development and qualification. As SME, you will design and execute analytical strategies, support biotherapeutics development through late-stage and commercialization, mentor junior staff, and produce high-quality documentation for

Qualifications

• PhD in Biophysics, Biochemistry, Analytical Chemistry, Biochemical Engineering (or MS/BS with related experience).
• Strong protein analytics and background in formulation development and analytical methods development/qualification.
• Ability to communicate complex data to diverse audiences.
• Experience with CGMP and GDP practices.
• Capable of independent and collaborative work in a fast-paced environment.

Responsibilities

• Execute experiments to support project goals using HPLC/UPLC, CE, UV/Fluorescence, and biophysical methods.
• Serve as SME for analytical methods and troubleshooting.
• Design analytical experiments for formulation, methods development, qualification/validation, and stability.
• Develop analytical strategies to support product development and regulatory submissions.
• Generate high-quality documentation for publication and regulatory review.
• Mentor junior scientists and perform peer reviews of data and reports.
• Manage timelines and resources to meet milestones and advise leadership on status and challenges.

Skills

Protein analytics

Communication

Data analysis tools

Independent work

CGMP/GDP knowledge

Education

PhD in Biophysics/Biochemistry/Analytical Chemistry/Biochemical Engineering

MS with 5 years related experience

BS with 7 years 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 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

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.