Associate Principal Scientist, Adjuvant CMC SME

Associate Principal Scientist, Adjuvant CMC SME

Introduction to Role 

Join our Vaccines Drug Product Development team to shape the next generation of preventative therapies. We are seeking a highly motivated Associate Principal Scientist with deep experience in vaccine adjuvants and complex, co-formulated drug products. You will independently design and develop formulations and drug product processes spanning Phase 1 through pivotal clinical development, with a focus on multi-antigen/adjuvant combinations and other vaccine modalities. You will drive development strategies, influence CMC decisions, manage external partners, and connect near-term deliverables to long-term patient impact. 

Key Responsibilities 

• Adjuvant and Vaccine Formulation: Lead efforts to develop co-formulated multi-antigen/adjuvant (aluminum-based, lipid-based, and novel adjuvants) products. More broadly develop and optimize formulations for mRNA-LNPs, bioconjugates, virus-like particles (VLPs), and recombinant proteins. 

• Drug Product Process Design and Scale-up: Design fit-for-purpose drug product processes (e.g., mixing, suspension handling, encapsulation, sterile filtration, aseptic fill-finish, lyophilization when applicable), conduct scale-up and process robustness studies, and build process-product understanding and support development across clinical phases. 

• GMP and External Manufacturing: Translate processes into GMP-ready operations; review batch records; coordinate tech transfer to internal sites and CMOs/CDMOs; provide on-floor and remote support for engineering and GMP batches. 

• Cross-Functional Leadership: Serve as the Drug Product CMC representative on vaccine program teams; collaborate closely with Drug Substance, Analytical Sciences, Regulatory, Quality, Clinical, Supply Chain, and Project Management to align strategy and execution. 

• Regulatory Authoring and Health Authority Interactions: Author and review CMC sections for INDs, BLAs, and MAAs; contribute to responses to information requests and support health authority queries with clear scientific rationales for formulation and process decisions. 

• Analytical Strategy Interface: Partner with analytical teams to define fit-for-purpose methods supporting vaccine and adjuvant characterization (e.g., potency/antigen integrity, particle size, encapsulation efficiency, adsorption profiles, residuals, sterility/endotoxin), and ensure data quality supports formulation selection and process control. 

• Technical Leadership and Communication: Plan and execute experiments; analyze and interpret data; deliver concise, decision-driving summaries to internal stakeholders and external partners; present findings at internal forums and scientific meetings as appropriate. 

• Documentation and Compliance: Write protocols, reports, and technical risk assessments; ensure compliance with cGMP, GLP where relevant, and corporate quality standards; maintain laboratory notebooks and support equipment qualification/maintenance as needed. 

Education & Experience Requirements 

• Education: BS, MS, or PhD in Chemistry, Biochemistry, Pharmaceutics, Chemical/Biochemical Engineering, Immunology, or related field. 

• Experience: BS: 10+ years; MS: 7+ years; PhD: 5+ years in biopharmaceutical or vaccine development settings. 

• Demonstrated expertise in vaccine adjuvant systems (aluminum salts, lipid-based systems, other novel adjuvants) and co-formulated multi-antigen/adjuvant products. 

• Hands-on experience with one or more modalities: mRNA-LNPs, bioconjugates, VLPs, recombinant protein vaccines. 

• Proven track record in GMP manufacturing, tech transfer to CMOs/CDMOs, and clinical supply support. 

Desired Skills & Experience 

• Formulation Development: Strong understanding of vaccine formulation principles, including adsorption kinetics, antigen–adjuvant interactions, buffer/excipient selection, stability (chemical, physical, colloidal), and immunogenicity considerations relevant to product design. 

• Process Engineering: Experience with unit operations relevant to vaccines (e.g., LNP formation via microfluidics, homogenization/emulsification, suspension management, sterile filtration, aseptic filling, lyophilization assessment when applicable). 

• Analytical Interfaces: Familiarity with biophysical and biochemical 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. 

• CMC Strategy and Documentation: Experience reviewing batch records, authoring IND/BLA/MAA CMC sections, and supporting health authority interactions. 

• Cross-Functional Ways of Working: Skilled at interfacing with CMC project leader, Clinical, Regulatory, Quality, Drug Substance, Supply Chain, and Program Management to align technical plans with program milestones and risk posture. 

• External Collaboration: Comfortable negotiating scope and timelines with CMOs, overseeing execution, resolving deviations, and driving continuous improvement. 

• Data and Decision Quality: Ability to connect experimental outcomes to program decisions; build evidence packages that withstand internal governance and external scrutiny. 

Ways of Working and Behaviors 

• Proactive and Motivated: Anticipates risks and opportunities; drives timely, high-quality execution without close supervision. 

• Engaged and Collaborative: Builds strong relationships across disciplines; communicates clearly and respectfully; fosters transparency and shared accountability. 

• Patient Impact Focus: Passionate about translating technical work into better patient outcomes; prioritizes decisions that advance quality, safety, and supply reliability. 

• Systems Thinking: Connects the what to the how—navigates complex technical problems, aligns stakeholders, and maintains momentum while understanding how work fits within Drug Product and the broader CMC landscape. 

• Scientific Rigor and Integrity: Upholds data integrity, methodical experimentation, and clear documentation; embraces feedback to improve outcomes. 

Working Model 

We value in-person collaboration and operate, on average, a minimum of four days per week from the office while maintaining flexibility to balance individual needs and team priorities. 

Location and Travel 

• Primary Site: Gaithersburg, MD (Biopharmaceuticals R&D) 

• Travel: Up to10% travel, primarily to CMOs/CDMOs, internal manufacturing sites, and health authority or cross-functional meetings as needed for tech transfer and GMP support. 

Why AstraZeneca?