• Directed CMC activities for Imugene’s CF33 oncolytic virus and B-cell vaccine programs in a fully remote role.• Oversaw process, analytical and formulation development, along with external manufacturing of clinical trial materials at CDMOs.

• Provided consulting regarding CMC development for viral therapeutics, resulting in full-time senior level role with client.

• Led a high-performing team of 14 scientists, advancing virus and protein-based projects from discovery to First-in-Human (FIH) trials.• Oversaw development and manufacturing processes for cutting-edge vaccine candidates, including mRNA, oncolytic viruses, and viral vectors.• Contributed to strategic leadership as a member of the Cancer Vaccines and Immunotherapeutics Executive Leadership Team.• Pioneered mRNA production and LNP formulation capabilities, enhancing the group's expertise in novel vaccine technologies.• Directed CMC efforts for an innovative adenovirus/mRNA-based cancer vaccine program, managing all development and manufacturing aspects.• Established bispecific antibody production capabilities, expanding the team's technical repertoire.

• Managed a team of up to 14 scientists, driving virus and protein-based projects from discovery through FIH stages.• Led process development for oncolytic virus projects, including a tripartite collaboration with a key collaborator and international CDMO.• Invented a novel production/purification process for oncolytic vaccinia virus, achieving over 50-fold increase in virus production and 200-fold improvement in purity (see patents).• Executed successful tech transfer and scale-up to a 500 m² bioreactor process, overseeing Phase 1 clinical trial manufacturing at a CDMO.• Authored CMC sections for IND filings, receiving no regulatory queries, demonstrating excellence in regulatory compliance.• Evaluated and selected CDMOs, representing the department during RFP processes to ensure optimal partnerships.

• Directed a team of 11 scientists in developing production processes for diverse vaccine candidates, including proteins, conjugates, viral vectors, and viruses.• Managed tech transfers of developed processes to internal sites or CDMOs for clinical trial production, ensuring seamless transitions.• Led cross-functional teams for anti-PCSK9 and anti-IgE peptide-CRM197 vaccine programs, overseeing process, analytical, and formulation development.• Advanced influenza vaccine development by leading upstream and downstream processes for whole inactivated virus vaccines across multiple strains.• Streamlined adenovirus production, successfully transferring processes from a CDMO and overseeing internal production for regulatory toxicology studies.

• Managed and mentored staff, including direct supervision of two scientists and matrix leadership of junior team members.• Core team member for multiple viral and therapeutic vaccine programs, contributing to strategic project development.• Ensured project continuity by overseeing equipment and team relocation from the UK to the USA.• Directed protein expression and cell culture operations, enhancing the team's capabilities in mammalian systems.• Led early-stage process development for a clinical small molecule-conjugated vaccine targeting nicotine addiction.• Developed methods for virus-like particles (VLPs), and viral glycoproteins production for pre-clinical studies and transferred methods to partner lines.

• Spearheaded cell culture and fermentation projects, designing and executing upstream process characterization and second-generation production processes.• Collaborated across disciplines and sites, contributing to process validation and co-development for multiple monoclonal antibody (mAb) projects.• Led upstream process characterization for a lead mAb project, overseeing scale-up and PPQ batches at a CDMO.• Developed a scale-down model replicating 12,000 L production performance at a 1.8 L laboratory scale.• Establised a perfusion-based mAb production system, achieving a 10-fold increase in volumetric antibody output over the fed-batch platform process.• Created proprietary serum-free media and feeds, matching production levels of commercial formulations through systematic DOE approaches.• Established an internal protein purification group, managing equipment procurement, recruitment, and staff training.• Enhanced adenovirus production for a gene therapy candidate, increasing yield by 100%.• Acted as a DOE expert and mentor, fostering statistical experimental design proficiency within the group.