Associate Principal Scientist, Adjuvant CMC SME

AstraZeneca•Gaithersburg, MD

1d•Hybrid

About The Position

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.

Requirements

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.
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.
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).
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.
Experience reviewing batch records, authoring IND/BLA/MAA CMC sections, and supporting health authority interactions.
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.
Comfortable negotiating scope and timelines with CMOs, overseeing execution, resolving deviations, and driving continuous improvement.
Ability to connect experimental outcomes to program decisions; build evidence packages that withstand internal governance and external scrutiny.
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.

Responsibilities

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