Experience

Imugene Limited

• Australia
• Biotechnology Research
• 1 - 100 Employee

• Vice President of CMC

  • Oct 2022 - Present



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director - Bioprocess & Analytical

  • Oct 2021 - Jun 2022

• Associate Research Fellow - Team Leader. Vaccine Research & Development

  • Apr 2016 - Oct 2021

  • Management of protein and virus production for multiple vaccine research projects from discovery to FIH, leading a team of up to 14 scientists.• Member of the Early Bioprocess Development Leadership Team and Cancer Vaccines and Immunotherapeutics Executive Leadership Team.• Development, tech-transfer, and manufacturing oversight of production processes for vaccine candidates including mRNA, Oncolytic viruses & Adenovirus.• Evaluation and selection of CDMO partners as part of RFP process. Review of SOW’s and work packages.• Release assay development and assay qualification in support of adenoviral, oncolytic virus and mRNA vaccine programs.• Formulation development. Including initial pH/buffer/excipient screening, formulation nomination studies and drug administration instruction studies in support of clinical programs.• Process development lead for multiple vaccinia-based oncolytic virus projects including 3-way collaboration between Pfizer, collaborator and international CDMO. Member of Joint Steering Committee overseeing collaboration.• Lead inventor of novel, production/purification process (see patents) for oncolytic Vaccinia virus utilizing packed bed bioreactor capable of yielding >50 fold improvement in virus production from existing process and > 200-fold improvement in product purity over published competitor data.• Directly oversaw engineering and clinical trial manufacture as person-in-plant. Successfully scaled up production process from to 500m^2 fixed bed bioreactor and produced Phase 1 clinical trial materials.• Lead author of CMC sections for successful IND filing which received no queries from regulatory agency.• Implemented mRNA purification and LNP formulation capability within group. Represented department on cross-site mRNA process development team to develop mRNA production and LNP formulation processes.• Established bispecific antibody production capability within team – including expression, purification and redox assembly. Show less

• Senior Principal Scientist - Team Leader. Vaccine Research & Development

  • Aug 2010 - Apr 2016

  • Responsible for recruitment, development, and scientific oversight of a team of up to 11 scientists.• Management of protein, virus and bioconjugate production for multiple vaccine research projects from discovery to FIH.• Development of scalable production processes for vaccine candidates including protein antigens, peptide/small-molecule conjugates, viral vectors and whole-inactivated virus.• Tech transfer of developed processes to internal or CDMO sites for clinical trial production. • Process/analytical/formulation team lead overseeing activities across multiple workstreams for anti-PCSK9 and anti-IgE peptide-CRM197 vaccines.• Cross-site, interdisciplinary team representative for clinical anti-IgE project – both conjugation and VLP production.• Designed scale-down production process and employed QbD principles to design DOE-based LPQ studies for peptide conjugated vaccine candidates using different conjugation chemistries. •Successfully scaled conjugation processes, performed process robustness studies, and tech-transferred processes to internal clinical production site.• Designed and equipped laboratories for virus production and purification within Vaccine Research.• Oversaw development of serum-free, perfusion-based, high cell density suspension cell (MDCK) production process for influenza virus production. • Led process development for upstream and downstream purification processes for whole inactivated influenza virus vaccine process for multiple virus strains. • Designed and implemented viral inactivation procedure – utilizing DOE-based optimization studies for viral inactivation unit operation.• Tech-transferred adenovirus production/purification process from CDMO to Pfizer to allow internal process optimization of Phase 1 clinical process.• Oversaw internal RegTox production of adenovirus drug substance.• Authored and reviewed development/technical reports detailing process optimization work in support of IND filings. Show less

• Principal Scientist- Vaccine Research & Development

  • Oct 2007 - Jul 2010

  •Management of 2 members of staff. Additional matrix supervision of junior scientists on project specific basis.•Project core team member for multiple viral and therapeutic vaccine programs representing Protein Sciences team.•Oversaw the relocation of Vaccine Research Protein Sciences equipment and group members from UK to USA ensuring continuity of project goals, rapid re-establishment, and expansion of group post-relocation.•Oversight of all protein expression and mammalian cell culture work within team.•Oversaw early-stage process development of clinical small molecule conjugated vaccine (anti-Nicotine vaccine).•Led expression and purification method development of multiple virus like particles (VLP).•Delivered multiple purified recombinant viral glycoproteins for pre-clinical administration and successfully transferred methods to internal partner lines.•Optimised transient protein expression from HEK293 mammalian expression system to increase protein production approx. 10-fold from standard process.•Successfully developed affinity chromatography methods for purification of viral glycoproteins from inactivated virus to allow direct comparison of immunogenicity with recombinant protein counterparts.•Developed protein refolding platform technology for early-stage preclinical targets. Show less

• Principal Scientist - Bioprocess Development Group, Pfizer Global Manufacturing. Sandwich, UK

  • May 2001 - Oct 2007

  Roles & Responsibilities• Responsible for the conception, design and execution of cell-culture and fermentation projects. Including upstream lab-scale process qualification studies and development of second-generation production processes for biological products.• Key author of lab-scale process qualification reports used to support the regulatory filing of Pfizer lead monoclonal antibody product.• Member of interdisciplinary teams spanning Pfizer and external partners as part of my role on the process validation team for multiple monoclonal antibody projects• Recognised group expert and mentor for the application of statistical design of experiments• Supervision of intern students and junior members of staff, including experimental planning, analysis and interpretation of data. • Authoring, review and approval of SOPs.Achievements• Led upstream lab-scale process qualification of lead monoclonal antibody project which was recognised with excellence award and promotion within the group.• Successful scale-up and process transfer of multiple monoclonal antibody products to CMO.• Designed and implemented a laboratory scale-down model (1.8L working volume) to yield equivalent process performance to 10,000L+ production culture • Developed a continuous perfusion based production system for monoclonal antibody production, yielding a 10-fold increase in antibody output compared to fed-batch platform production system.• Developed an in-house serum-free production media to yield equivalent antibody production to proprietary formulation.• Instigated the protein purification group within the BDG.• Introduced systems and documentation to Biologicals group to ensure GLP compliance Show less



Cantab Pharmaceuticals

• Process Development Scientist

  • Jan 1996 - May 2001

  Roles & Responsibilities • Development of a production process for a Disabled Infectious Single Cycle (DISC) Herpes Simplex II viral vaccine including: • The development of novel virus harvest methods and initial virus recovery procedures. • Improvement of virus production in roller bottle and bioreactor cultures. • The development of serum and animal product free microcarrier production systems. • The scale-up of serum-containing microcarrier process for virus production to final manufacturing scale. • Line manager responsibility for one member of staff. Achievements • Developed novel non-disruptive virus harvest methods that yielded improved virus titres with greatly reduced host-cell protein/DNA impurities by utilising cell surface to virus interactions. • Achieved a 40 fold increase in virus production from standard roller bottle production system. • Developed a trypsinisation procedure to allow microcarrier to microcarrier transfer of adherent cells • Scaled up a microcarrier-based virus production process to 500L working volume scale in collaboration with our external partners. • Co-authored process transfer documents for upstream vaccine production process to external partners. Show less