Director, Analytical Services

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. 

Position Summary:

KBI Biopharma is seeking a scientifically accomplished and visionary leader to serve as Director, Analytical Services overseeing Particle and Biophysical Core Labs. This role is central to delivering high-quality analytical support for biologics development, spanning early-phase through commercial programs. The Director will lead a team of expert analysts and scientists, driving innovation and excellence in particle characterization and biophysical analysis.

Responsibilities:

• Provide strategic and operational leadership across core labs specializing in particle characterization, protein biophysics, and higher-order structure analysis.

• Oversee forensic particle identification and root cause analysis, including real-time compatibility testing and simulated administration studies.

• Lead development and execution of integrated scopes of work and ad hoc rapid-turnaround testing to support client programs.

• Ensure delivery of comprehensive, high-quality, and easily interpretable data using state-of-the-art instrumentation.

• Collaborate cross-functionally with formulation, process development, and regulatory teams to support product characterization and troubleshooting.

• Mentor and develop scientific staff, fostering a culture of technical excellence, innovation, and client focus.

• Particle Characterization:

  • Subvisible: Imaging Flow Cytometry (IFC), Light Obscuration (LO), Micro-Flow Imaging (MFI)

  • Visible: Visual Inspection, Raman Microspectroscopy, FTIR Microscopy, SEM-EDS

  • Nanoparticle: DLS, NTA, AUC, IFC

  • Image classification via proprietary software with in-house ML models trained on >300k images

• Biophysical Analysis:

  • Protein conformation, stability, and aggregation studies

  • Equipment includes: AUC, FTIR, MMS, CD, Fluorimeter, DSC, DLS, DSF, SEC-MALS, Gel electrophoresis

Requirements:

• Ph.D. in Biochemistry, Biophysics, Pharmaceutical Sciences, or related field with 10+ years of relevant industry experience or equivalent combination of education and experience

• Proven leadership in analytical development within a CDMO or biopharma setting

• Deep expertise in particle and biophysical characterization techniques and regulatory expectations

• Strong communication, project management, and client engagement skills

• Extensive experience characterizing cytokines, interferons, growth factors, monoclonal antibodies and conjugates, vaccines, viral vectors, and biosimilars

Salary Range: $173,000 - $238,700

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting upon hire and employee recognition programs.   

About KBI: 

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com. 

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. 

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.