Senior Scientist, Vaccine Drug Product Development

About the Company

Responsibilities

• ● You will work in a laboratory environment focused on vaccine drug product development, supporting programs from early formulation screening through clinical manufacturing readiness. Additionally, you will:
• ● Vaccine Formulation Development : Design and execute formulation studies for vaccine drug products, including co-formulated multi-antigen/adjuvant combinations and other vaccine modalities. Evaluate antigen-adjuvant interactions, excipient compatibility, and stability to inform pipeline advancement decisions.
• ● In Vitro Characterization : Perform experiments to evaluate formulation attributes such as antigen integrity, adsorption/desorption profiles, particle size, encapsulation efficiency, and colloidal stability. Generate data packages that support formulation down-selection and process development decisions.
• ● Drug Product Process Design and Scale-Up : Design fit-for-purpose drug product processes (e.g., mixing, encapsulation, sterile filtration, lyophilization). Conduct scale-up and robustness studies to build process-product understanding across clinical phases. Contribute to technology transfer activities to manufacturing sites or CMOs/CDMOs.
• ● Documentation and Regulatory Authoring : Author technical reports, protocols, and development summaries. Draft and contribute to CMC sections for INDs, and BLAs (i.e., process descriptions, formulation justifications, clinical compatibility). Maintain documentation in compliance with internal practices.
• ● Cross-Functional Representation : Represent Drug Product on CMC sub-teams; collaborate with other functions to align formulation and process plans with program timelines.
• ● Scientific Contribution and Lab Operations : Present findings at internal forums; contribute to external publications or conferences where appropriate. Stay current with emerging scientific literature and technology. Support coordination and maintenance of laboratory equipment.

Requirements

• ● Required Skills & Experience
• ● Formulation Development : Strong understanding of vaccine formulation principles, including adsorption kinetics, antigen-adjuvant interactions, buffer/excipient selection, and stability assessment (chemical, physical, colloidal). Ability to independently design and execute formulation studies with clear decision criteria.
• ● In Vitro Characterization : Familiarity with biophysical characterization techniques such as DLS, HPLC/UPLC, LC-MS, UV/Fluorescence, ELISA/Binding assays, DSC/DMA, zeta potential, encapsulation efficiency, particle size and PDI, adsorption/desorption profiling, residual solvent/detergent analysis, Karl Fischer, osmolality, sterility/endotoxin, and appearance/particulate assessments.
• ● Data Interpretation & Decision-Making : Ability to design experiments with clear decision criteria, critically interpret results, and connect experimental outcomes to inform next steps.
• ● Process Engineering : Familiarity with unit operations relevant to vaccines (e.g., homogenization/emulsification, sterile filtration concepts, or LNP formation via microfluidics). Exposure to process scale-up considerations is a plus.
• ● Scientific Communication : Ability to clearly document experimental work, summarize findings in written reports, and present data to multidisciplinary teams.
• ● Collaboration : Strong communication and interpersonal skills, with the ability to work effectively across multidisciplinary scientific teams.
• ● Process Engineering : Experience with unit operations relevant to vaccines (e.g., homogenization/emulsification, sterile filtration, LNP formation via microfluidics, lyophilization). Hands-on experience with process scale-up or tech transfer is preferred.
• ● CMC and GMP Familiarity : Experience working within or interfacing with GMP manufacturing environments, reviewing batch records, or coordinating with CMOs/CDMOs.
• ● Regulatory Authoring : Direct experience authoring or reviewing CMC sections for regulatory filings (IND, BLA).
• ● External Scientific Engagement : Track record of conference presentations, publications, or patent contributions.
• ● Ways of Working and Behaviors
• ● Proactive and Motivated : Anticipates risks and opportunities; drives timely, high-quality execution with minimal supervision.
• ● Collaborative and Engaged : Builds strong relationships across disciplines; communicates clearly; fosters transparency and shared accountability.
• ● Patient Impact Focus : Passionate about translating technical work into better patient outcomes; prioritizes quality, and safety.
• ● Scientific Rigor and Integrity : Upholds data integrity, methodical experimentation, and clear documentation; embraces feedback to improve outcomes.
• ● Working Model
• ● This is a lab-based position with an on-site requirement. However, there is flexibility for remote work based on individual needs and team priorities.
• ● Location and Travel
• ● Primary Site : Gaithersburg, MD (Biopharmaceuticals R&D)