Professional Experience

• • GSK3844766A (RSV) – Older Adult – Recombinant Protein adjuvanted 

  • GSK3888550A (RSV) – Maternal – Recombinant Protein 

  • Platform Technologies (SAM) – Self-Amplifying Messenger RNA 

  • Adjuvant Technologies (Alum-TLR7) – TLR7 agonist adsorbed to alum 

  • Cross-functional activities

• • Comparability Template used for future IND submissions 

  • RSV Drug Product Process Description for Technical Transfer 

  • RSV Production Report for Process Compatibility Study 

  • RSV Production Summary Report for Toxicology and Clinical Studies 

  • SAM Process and Product Comparability Report for Development and Clinical Trial Material 

  • SAM Process and Product Comparability Report for Toxicology and GMP Drug Product Lots 

  • SAM Diluent Stability Report 

  • Composition of RSV Phase III Drug Product and Reconstituted Vaccine

  • Addendum for RSV Phase III Placebo and Reconstituted Placebo

  • RSV Platform Placebo Proposal 

  • RSV Adjuvant Compatibility for Phase III Formulation

  • RSV In-Use Stability for Phase III Formulation

Led the Following Studies

• • • SAM Diluent Stability 

    • RSV Platform Placebo

    • RSV Adjuvant Compatibility

    • RSV In-Use Stability

Appointed Lead User of the liquid chromatography lab 

• • • Responsibilities: – maintaining and managing all instruments (– perform routine maintenance and cleanings – manage maintenance schedules – troubleshoot issues for all users) – training all users on new and current methods 

Appointed Representative for Alignment meetings between R&D and GMP manufacturing 

• • • Authored: – Template for technical transfers – Process mapping documents 

Appointed to lead 5S Initiative to organize and maintain the Drug Product Development lab space 

• • • Achievements: – Set the standards and authored the model used for all 5S initiatives in other departments – Awarded Global Employee Recognition for having a major impact outside of working group 

US Representative for all 3D printing activities 

• • • Deliverables: – 3D Printer Workshop – Developed models used to improve the efficiency of lab activities and used to improve the organization, cleanliness, and safety of the lab – Developed molecular models for visualization and to use as presentation tools 

Global Employee Recognition: Silver  

• • • Feb 2019: Led 5S Initiative in Drug Product Development Labs; silver awarded for having a major impact outside of working group  

Global Employee Recognition: Bronze 

• • • Aug 2020: Led the TFF process (core unit operation) to produce a toxicology batch in development space for the first time in this department's history. This includes all preparation of documents related to this process, execution of the process, and thorough real-time documentation using GMP-like standards. (SAM)

    • July 2020: Evaluated necessary options and met with suppliers to replace a piece of high value equipment (~$1M USD) in order to enable toxicology lot production within developmental labs. Compiled information into a proposal for the department's 2021 PIP budget.

    • June 2020: Led an adjuvant compatibility and in-use study including designing, planning, executing, and summarizing the analytical results in a report to support the Phase III regulatory filing (RSV) 

    • Apr 2019: Independently executed stability study, collected all data, and provided interim stability reports; ultimately supported self-life extension (SAM)  

    • Dec 2018: Presentation and demonstration on 3D printing at R&D Days 

    • Aug 2018: Supported critical activities needed to ensure successful manufacture of the first clinical drug product batch (RSV) 

All details related to formulations and documents written are confidential and not included

Vaccines formulated: 

MMR, Varilrix (varicella) 

Job requirements: 

Carried out secondary production of lyophilized vaccines by following Standard Operating Procedures (SOPs), kept up with current Good Manufacturing Processes (cGMP), used aseptic technique in classified areas (Grade A/B/C/D). 

Equipment used: 

Bosch vial filler, lyophilizer, Bosch vial washer, Bosch vial capper, Seidenader automated visual inspection, stainless steel vessels (sizes: 5L - 85L), peristaltic pumps 

Technical documents written/reviewed: 

Master Batch Production Records, Investigations, Deviations, Standard Operating Procedures, Job Safety Assessments, Job Aids