Greater Philadelphia
• CMC experience in immuno-oncology and retinal disease therapeutic areas developing small molecule, large molecule, mRNA vaccine, and viral modalities(AAV gene therapy, MVA, HSV-1, Adenovirus) drug products • R&D pharmaceutical industry experience leading and contributing on cross-functional teams to meet accelerated program timelines (pre-NME to BLA)
BioTherapeutics, Large Molecule Drug Product Development (DPD) DPD Scientific Integrator and Formulator for gene therapy (AAV) targeting retinal diseases, viral modalities (Oncolytic Viruses: MVA, HSV-1) and large molecule mAbs (bispecifics) for oncology - Formulation Development - Manufacture and Fill/Finish - Clinical Dosing Preparation and Administration - Regulatory Filings (IND, BLA, FDA, EMA) - IP Strategies
Preclinical Development, Sterile Formulations Vaccine Development - Supported rapid advancement of multiple programs in the Merck Vaccines Pipeline - Lead Formulator for vaccine program: Optimized and implemented small scale, rapid manufacture process to quickly produce vaccine candidates enabling identification of a stable and effective formulation allowing the team to be able to prioritize viral targeting strategies and accelerate go/no-go program decisions - Optimized process parameters to enhance stability, processability, and compositional robustness of vaccine formulations with high complexity non-standard manufacturing processes - Contributed to design and execution of imaging studies to study biodistribution of delivery vehicles in animal models Lead Formulator for Oncology Small Molecule program - Led cross-functional team in program technical discussions and troubleshooting - Designed and executed formulation development experiments - Composition selection and robustness – Executed DOEs to finalize final market formulation - Characterized drug product risks and interactions with final image materials, fill finish process exposures, and dose preparation and delivery - Authored regulatory filings for US and international regulatory agencies - Authored Procedure Manual for clinical dosing of drug product - Led multiple GMP clinical manufacture campaigns at external CMOs - Responsible for technology transfer of fill finish process
Combined an engineering-based PRINT (Particle Replication In Non-wetting Templates) particle fabrication method with biomaterials and pharmaceutical research to design efficient inhalable drug delivery vehicles - Fabricated non-spherical, aerodynamically shaped particles composed of polymer, protein, or drug matrices via the PRINT process - Investigated the influence of shape on phagocytosis kinetics to better engineer particles to target or de-target alveolar macrophages for pulmonary drug delivery applications - Characterized particle deposition in the lung using aerosol sizing techniques - Analyzed murine immune response to particles delivered via the pulmonary route - Formulated prodrugs and analyzed release kinetics from drug-loaded particles
Inhaled Product and Device Technology Group Investigated novel blending technology to enable industrialization of GSK’s particle engineering platforms - Resulted in the purchase of the technology for further application in R&D - Characterized API and excipient levels in dry powder inhaler formulations by HPLC
- Characterized and assessed the efficacy of targeted RNA actives for gene therapy applications - Developed formulations of plasmid-coated nanoparticles for scale-up processing - Lab Manager, Biology Group - Responsible for acquisition of equipment and set-up of RNA lab