Senior Scientist

Position Overview

The Senior Scientist will lead vaccine and biologic formulation development and clinical stability projects for investigational drug products. The position combines scientific leadership, experimental planning, data interpretation, formulation characterization, regulatory document support, and mentoring.

Responsibilities

• Lead multiple formulation development and clinical stability projects, including experimental design, timelines, data interpretation, and coordination with internal and external collaborators.

• Protect data integrity and provide technical, theoretical, and strategic guidance to project team members.

• Serve as a subject matter expert on pharmaceutical compounding and administration of investigational drug products.

• Evaluate stability and compatibility data to ensure pharmaceutical compounding and clinical administration methods meet target product profiles.

• Coordinate formulation analytical testing support, balance resource allocation, and monitor completion of deliverables.

• Prepare, review, edit, and verify technical reports and protocols for formulation, stability, and method development studies.

• Coordinate equipment maintenance and servicing and draft, review, and update relevant standard operating procedures.

• Maintain the clinical excursion reporting system, evaluate affected product quality, coordinate with stakeholders, and manage supporting documentation.

• Address product quality inquiries and author and review regulatory filings in collaboration with regulatory affairs staff.

• Develop assays and technologies for vaccine and biotherapeutic characterization, evaluate new instruments and methods, and confirm assay results.

• Coordinate scientific literature discussions and present research at national conferences and scientific meetings.

• Provide scientific interpretation and guidance to management, mentor junior scientists, and train users in data and analysis methods.

Required Qualifications

• Ph.D. in chemistry, biochemistry, chemical engineering, or a related discipline.

• Expert knowledge of protein chemistry, protein and vaccine formulation, and the bioanalytical and biophysical properties of proteins and vaccines.

• Extensive knowledge of pharmaceutical compounding requirements and clinical-use stability, with hands-on experience in clinical stability evaluation studies.

• Extensive experience designing, executing, and interpreting protein or vaccine formulation and stability studies, with practical knowledge of development practices for clinical trials.

• Proven technical and theoretical expertise in one or more formulation science areas, such as biophysical characterization, particle analysis, colloidal stability, or thermodynamics.

• Extensive hands-on expertise, including data analysis and underlying theory, with four or more of the following techniques: ultraviolet-visible spectroscopy; fluorescence spectroscopy; circular dichroism or infrared spectroscopy; differential scanning calorimetry; isothermal chemical denaturation; rheology or viscosity; and particle characterization using dynamic or static light scattering, HIAC, or FlowCam.

• Experience drafting and reviewing relevant technical sections of regulatory documents, including investigational brochures and Investigational New Drug applications.

• Strong project planning skills, including timeline estimation, task coordination, and balancing priorities across multiple projects and collaborators.

• Proficiency with data analysis and Design of Experiment (DOE) software, such as JMP, Origin, GRAMS, Prism, or SigmaPlot.

• Excellent written, visual, interpersonal, and group communication skills.

Deliverables

• Provide experimental protocols, reports, data summaries, analyses, raw data, and project team updates as needed to meet project timelines and program needs.

• Meet with laboratory members to present updates as needed.

• Provide project updates to the federal task leader at least weekly.