Gabriela Albright

Experience in early stage/ Phase I drug product development in the US at the NIH. Responsible for planning and managing experiments from initial manufacturability assessment to clinical support at trials. 

Hands-on experience with physical characterization assays such as DLS, DSC, MFI, UV/Vis, and CD. 

Responsibilities in the past have included creating SOP's, training, developing data management systems, internal and external communication with stakeholders as well as preparing and management of data generated, data analysis, and conclusions. 

WORK EXPERIENCE

NATIONAL INSTITUTES OF HEALTH (NIH)/ 

VACCINE PRODUCTION PROGRAM (VPP) 

GAITHERSBURG, MD, USA

Formulation and Stabilization Sciences, 

Associate Scientist I, II                                                                                                                                            June 2016-April 2020

• Lead in the working-group responsible for harmonizing batch production records with representatives from upstream, downstream, and formulation groups to be used in product INDs.
• Designer for the data science committee for a newly built dynamic data management and tracking system using GitHub. 
• Responsible for writing and executing experimental protocols from initial risk assessment and characterization to toxicology release as well as forced degradation, technology transfer and clinical support of both nanoparticle vaccines and monoclonal antibodies. 
• Troubleshooting and maintenance of laboratory instrumentation.  
• Writing, reviewing and amending SOPs, technical reports and interim reports for optimization of existing platforms as well as additions for data analysis. 
• Provide analytical support across departments in collaborative work on adjoining projects. 
• Experience executing studies to determine an optimized buffer for new products (vaccines and monoclonal antibodies) including design of experiments, characterization, and excipient screen and optimizations to downselect buffering components and their concentrations per product.
• Experience in performing stability monitoring studies performed with the goal of down selecting buffer candidates to an optimal final formulation including evaluation of freeze and thaw stress, accelerated storage, and agitation studies. 
• Experience in technology transfer studies performed with the goal of transferring the final process to the manufacturing plant to scale up for production and fill including evaluating the impact of sterile filtration, loss due to glass adhesion as well as the rate freezing and thaw on the product critical quality attributes during manufacturing. 

INNOSPEC FUEL SPECIALTIES

NEWARK, DE, USA

Refined Fuel Additives Formulation and Stability, Laboratory Technician                                             April 2013-May 2016

• Trained new employees in industry methods as well as good laboratory practices and emergency safety procedures, protocol, and proper protective equipment.
• Adept in over 22 ASTM methods including analysis of corrosion caused by water in hydrocarbons, dye analysis in application with fuels and analysis of competitor products.
• Corresponded data and results of long-term projects via Technical Reports, Excel and R software reports, including analysis such as error propagation or trends observed.
• Designed, implemented and maintained a new inventory database for use by multiple staff that is responsible for tracking the location, identification, supplier, age, volume and HMIS rating of over 1,000 items as well as the categorization of each item based on product classification and flammability.
• Managed performance compatibility and stability evaluations for multiple product formulations on a variety of projects simultaneously.
• Maintained and recorded in scientific notebooks, including oversight of their contents for multiple projects involving multiple parties.
• Outlined and prepared standard operating procedures to be used for daily reference and training purposes.

MASTER OF SCIENCE, BIOTECHNOLOGY                                                                                                                       December 2021

SPECIALIZATION IN MANAGEMENT

UNIVERSITY OF MARYLAND GLOBAL CAMPUS

ADELPHI, MARYLAND, USA

BACHELOR OF SCIENCE, BIOCHEMISTRY

May 2016                                                                   

MINOR IN CHEMISTRY 

UNIVERSITY OF DELAWARE 

NEWARK, DELAWARE, USA