Associate Principal Scientist, Materials and Biophysical Characterization

Overview

Associate Principal Scientist – Materials and Biophysical Characterization – The Materials and Biophysical Characterization group, part of the Pharmaceutical Analysis and Digital Technologies organization, seeks a highly self‑motivated and innovative scientist with deep knowledge and problem‑solving skills in biotherapeutics characterization. The team builds mechanistic understanding of the interplay between formulation composition, stability, device, and process to ensure robustness and quality of drug substances and drug products in the biotherapeutics pipeline.

• Develop and implement biophysical and particle characterization tools for projects in a diverse biotherapeutics pipeline.
• Collaborate with process, formulation, and device functions as part of the CMC development team.
• Use scientific expertise to deliver creative solutions to challenging problems requiring deep analytical insight and critical thinking.
• Author technical reports and regulatory documents.
• Present technical data to internal and external stakeholders.
• Manage project tasks and timelines.

• Ph.D. in Biophysics, Biochemistry, Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related discipline with a minimum of 4 years of relevant industry experience.
• OR M.S. in an equivalent discipline with a minimum of 8 years of relevant industry experience.

• Hands‑on experience in biophysical characterization of proteins and peptides (Circular Dichroism, Infrared Spectroscopy, Differential Scanning Calorimetry, Analytical Ultracentrifugation).
• Experience analyzing biologics, protein/peptide stability, and protein–protein interactions.
• Experience with subvisible and submicron particle characterization tools (flow imaging microscopy, back grounded membrane imaging, flow cytometry, dynamic light scattering).
• Experience in biological formulation development and analytical method development.
• Understanding of protein aggregation mechanisms and the link between analytical methodologies.
• Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
• Demonstrated initiative, creativity, and innovative problem‑solving.
• Strong team player with excellent oral and written communication skills; ability to work independently and cross‑functionally.

• Characterization of lyophilized protein formulations.
• Characterization of protein–interface interactions (interfacial rheology, QCMD).
• Characterization of combination products for protein therapeutic delivery (e.g., autoinjectors).
• Experience in molecular modeling.
• Experience with various biologics modalities including peptides, monoclonal antibodies, antibody–drug conjugates, and fusion proteins.
• Knowledge of biomedical engineering, biophysics, and related analytical techniques.

Salary range: $ – $. The employee’s position within the range is based on education, qualifications, certifications, experience, skills, geographic location, and business needs. Eligible for annual bonus and long‑term incentive, if applicable.

• Medical, dental, vision, and other insurance benefits for employee and family.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Comprehensive benefits package with additional details available on the company website.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.