Resume

Project Coordinator III

Site Technical Services: Technical Transfer Team
July 2019 – Current
Pfizer (Contract Position)

• Assisted in coordination of PV manufacturing of drug substance intermediate
• Assisted with project management and timelines for multiple batches of monoclonal
  antibody (mab) product
• Collaborated with other departments supporting Gemtuzumab PV campaign: Quality
  Control Micro, Quality Control Analytical, Analytical Research and Development,
  Bioprocess Research and Development, Manufacturing (Upstream and Downstream)
• Authored reports and technical documents prior to manufacturing and project-close out
  reports for filing with boards of health
  • BLA filing portions (S.2.3), PV reports, downstream PPQ microbial control,
    impurity removal…etc.
• Analyzed data and trends of different batches from different labs
• Authored VBA programs to make repetitive tasks more automated; programs currently in use by other teams and project coordinators
• LIMS knowledge, data query and capture, PV sample management
• Researched and wrote document defining Q/Sigma for future STS PV reports
• Set endotoxin and bioburden limits for manufacturing of DSI with QC Micro
• Analyzed data from PV Campaign to support a Laboratory Investigation

Coordinator, Quality Control Raw Materials

Mar 2019 – May 2019
Brammer Bio (Contract Position)

• Worked on multiple client’s projects and maintained timelines for multiple projects
  undergoing manufacturing and testing
• Assisted with management of work flow of work through QC Raw Materials
• Collected test results from CTLs and provided data review
• Explained raw materials specifications and testing requirements to technical writing
  department
• Created documents utilizing Virtual Basic for Applications (VBA) programming
  language – streamlined timing of raw materials release for manufacturing
• Managed database of information kept by QC Raw Materials
• Coordinated raw materials testing in-house and at contract testing laboratories (CTLs)
• Proof-read and assisted technical writing team with Certificates of Analysis for raw materials
• Provided daily priorities to QC Raw Materials department for testing queue updates
• Worked with department Supervisor and Associate Director to improve department standards
• Worked daily with project managers, customer managers, and Procurement/Supply Chain teams to provide fast service and delivery of raw materials for manufacturing
• Coordinated shipping of raw materials to CTLs
• Became familiar with regulatory guidelines concerning raw materials testing and sampling

Associate Scientist, QC Global Stability

Oct 2018 – Mar 2019
Bristol-Myers Squibb (Contract Position)

• Assisted with statistical reports under a Senior Scientist utilizing JMP
• Stability protocol management
• Author/Revisor of cGMP documents
• Learned regulatory guidelines for stability of  biopharmaceuticals

Team Leader, Scientific Services

March 2018 – Oct 2018
ThermoFisher Scientific (Contract Position)

• LIMS Analyst and Inventory roles
• Trained new hires and managed schedules
• Managed shipping and receiving of drug samples for customer
• Managed inventory and retains of samples
• Performed routine machine maintenance

PCB Designer

Oct 2015 – Aug 2017
Newgrange Design

• Rapid prototyping
• Altium, Allegro, and OrCad design
• Schematic Design from the ground up
• Circuit design and re-design of previous work (ECO rework)
• ITAR standards and ISO 9001
• Worked with various companies
• Designed: medical devices, wearable devices, particle accelerators, …etc.