Brandon West Email & Phone Number

Raleigh, Nc, Us

Melbourne, Victoria, Au

- Serve as Sending Unit or Receiving Unit in global technology transfers of products/processes in/out of CSL Seqirus Manufacturing Sites or External Partner Manufacturing Sites - Manage the technical operations of biological processes (drug substance, drug product, formulation, fill, finish, inspect, pack) at CSL Seqirus facilities and Contract Manufacturing Organizations (CMOs)- Scale-up biopharma processes from development stage to commercial phase- Technical Lead in the process design, implementation, control strategy, qualification, and commercialization of mRNA and cell-culture vaccine products in respiratory therapeutic areas such as COVID-19 and influenza

Melbourne, Victoria, Au

- Lead global Fill/Finish technology transfers of Seasonal and Pandemic Influenza Vaccine Drug Products (pre-filled syringe and multi-dose vial finished dosage forms)- Support contract manufacturing operations across global network of internal and external sites (technical services, process development, manufacturing investigations, product quality impact assessments, change management)- Support the on-boarding, training, knowledge transfer, and success of colleagues within Global Technical Solutions Team

Melbourne, Victoria, Au

- Led technology transfer activities in support of global expansion and additional formulation/fill/finish/pack capacity for key Seqirus Flu Vaccine Products--> Conducted risk assessments, gap analyses, and feasibility assessments for projects/products--> Authored and reviewed Technology Transfer Plans and Engineering and Process Validation protocols and summary reports--> Served as Technical SME for Sending Site on Tech Transfer Team

Melbourne, Victoria, Au

- Supported Upstream Flu Cell Culture Fermentation + Virus Propagation Manufacturing Business Unit --> Performed routine process monitoring, tracking/trending, dashboarding, and data reporting --> Analyzed and communicated science-based, data-driven decisions based on cell growth profiles --> Provided daily shop-floor support of production steps including vial thaw, small scale shake flasks, wave bioreactors, single-use bioreactors, and large-scale cell expansion and infection bioreactors --> Authored product impact assessments for process deviations --> Led execution of process improvement/next-gen process implementation projects (ex: kLa studies, mixing studies, cell culture media development, process optimization, etc)- Served as Process Sciences SME for Support (Process Buffers, Medias, Solutions, Equipment Prep) Manufacturing Business Unit

Copenhagen, Dk

- Led and assisted in manufacturing process development and implementation in relation to new product launches and site-to-site product transfers- Led Scale-Up activities transferring products/processes from R&D, lab-scale, or pre-clinical phases- Led Process Performance Qualifications (PPQ)- Assisted in the planning, coordination, and execution of Site Aseptic Process Qualification / Media Fill Program- Supported daily manufacturing processes and aided in resolution of technical issues - Performed manufacturing/engineering/validation feasibility and cost analysis assessments of contract manufacturing bids

New York, New York, Us

*Hospira, now a Pfizer company (effective 9/3/2015)*-Support new product development related to critical product launches for company --> Identify Critical Process Parameters and Critical Quality Attributes, --> Conduct small-scale process engineering development studies, --> Provide technical support for commercial scale-up production activities,--> Optimize manufacturing processes, --> Perform statistical process control analysis on process indicators/outputs,--> Author Technology Transfer Plans/Reports and other relevant documentation-Serve as a technical resource on operations related challenges-Drive process optimization and operational excellence across all manufacturing business units and product platforms at the Hospira Rocky Mount site

Lake Forest, Il, Us

-Worked as Quality Engineer in the Biological Quality Department at Rocky Mount, NC facility (4th assignment within the Technical Professional Development Program (TPDP))-Completed and closed 15 Low or Medium Risk Level Biological Quality Exception Reports during a 3 month time span. The exception reports pertained to the Rocky Mount facility's Environmental Monitoring (EM) Lab deviations as well as EM related excursions and deviations in the Aseptic and TS Production Environments across a variety of different manufacturing lines and business units. Used Root Cause Analysis approach and investigation tools and implemented necessary Corrective and Preventative Actions (CAPAs).

Lake Forest, Il, Us

-Worked as Remediation Engineer within Rocky Mount Remediation Department focusing on remediation activities pertaining to the Engineering Department and Small Volume Parenteral (SVP) Manufacturing Business Unit.(3rd assignment within the Technical Professional Development Program (TPDP))-Managed and supported compliance projects relative to the Engineering Business Unit: -->Risk Assessments of Risk to Product from a manufacturing standpoint on 4 SVP Filling Lines -->Facility Upgrades and Room Classification Changes of Aseptic Manufacturing Line Areas-Provided Inspection/Audit support during Rocky Mount site Regulatory Inspections -Led bi-weekly Remediation Project Update Meetings with Site Remediation Project Owners, Directors, and Managers-Supported critical compliance projects relative to the SVP Business Unit: -->Continuous Particulate Monitoring System (CPMS) in aseptic manufacturing areas -->Site Gap Assessment of PIC/S Good Manufacturing Practice standards and Quality Systems

Lake Forest, Il, Us

-Worked as Quality Investigations Engineer in Quality Investigations group at Rocky Mount, NC facility (Second assignment within the Technical Professional Development Program (TPDP))-Completed and closed 15 Medium or High Risk Level Manufacturing Exception Reports during a 4 month time span. The exception reports pertained to the Rocky Mount facility's manufacture of Small Volume Parenterals ranging from process deviations across solution preparation, filling for terminal sterilization, filling for aseptic processing, and final product inspection, finishing, and packaging processes. Used Root Cause Analysis approach and investigation tools and implemented necessary Corrective and Preventative Actions (CAPAs).-Assisted in the investigation and closure of 2 Customer Complaints pertaining to the Rocky Mount Small Volume Parenteral Finishing and Packaging Manufacturing Business Unit.

Lake Forest, Il, Us

-Worked as Process Engineer in MS&T group at Rocky Mount, NC facility(First assignment within the Technical Professional Development Program (TPDP))-Generated process knowledge, mapped process flow, identified potential failure modes, and communicated technical knowledge to production areas in Large Volume Solutions IV Bag manufacturing process from incoming commodity stage to final product stage. -Conducted regular tracking and trending of Large Volume Solutions IV Bag manufacturing defects and defined and developed effective, sustainable system for collecting, trending, and reporting this defect data.-Provided day-to-day production support from a process engineering standpoint for Large Volume Solution IV Bag Manufacturing Business Unit. -Developed skills in areas of Process Capability Analysis, Failure Mode Effects Analysis (FMEA), and Pareto and Control Charting in support of manufacturing processes, key process indicators, and critical release criteria of medicine manufactured at Hospira Rocky Mount, NC facility. -Authored SOP for Biological Quality Business Unit for new Autodilutor Lab Instrument to be used to increase the capacity and reduce the man-hours required to perform final product release testing of medicine manufactured at Hospira Rocky Mount, NC facility.

*helped establish organization and development into 501(c)(3) non-profit*Director of Development:-Planned and managed fund-raising campaigns and activities-Identified and cultivated prospective donors -Monitored advancements and changes that were pertinent to raising money within the community and to the organization's mission and programs-Forecasted and evaluated the potential of fund-raising campaigns and activities-Managed personnel within the development department and interacted with other organization staff membersCoach/Volunteer:-Assisted in coaching and volunteer responsibilities at Kicking4Hunger events, camps, organization functions

Raleigh, North Carolina, Us

B.S. Biomedical Engineering, concentration area: Biomaterials-Summa Cum Laude-University Honors Program-Dean's List-Tau Beta Pi Engineering Honor Society

Austin , Texas, Us

-Summer intern in the Engineering Leadership Program within the Applications Engineering Department geared towards developing software and hardware components to be used in a variety of applications and industries.-Completed a project called "Angry Eagles" with the NI LabVIEW Product Marketing group. Modeled the current mobile application/game "Angry Birds", consisting of a fully functional video game programmed in LabVIEW 2011 equipped with physical user-input that was collected by NI DAQ hardware and sent wirelessly to a computer for processing and real-time game play. -Demonstrated Angry Eagles at NIWeek 2011 global tradeshow-Trained in LabVIEW software, NI hardware and data acquisition products, as well as product and business strategies as part of the Engineering Leadership Program. Received certification as a Certified LabVIEW Associate Developer (CLAD).-Worked in customer service providing phone and online support.