Ellen Blackwell Email & Phone Number

Portsmouth, New Hampshire, United States

* Authoring equipment design documents (User Requirement Specifications, Risk Assessments, Configuration Specifications) in concordance with FDA regulatory guidelines and industry best practices (ASTM, ICH, ISA, ISPE, PDA, PIC/S, and USP)* Executing self-designed protocols to support commissioning and qualification for Controlled Temperature Unit (CTU), Ultraviolet Visual spectrophotometer (UV/Vis), and autoclave systems* Reconciling existing validation life cycle document sets including vendor, design, and test documentation for UV/Vis, benchtop centrifuge, thermal validation system, and peristaltic pump systems* Composing commissioning test protocols (CTP), and installation and operational qualification (IOQ) protocols * Generating trace matrices, acceptance and release reports, and gap assessments for various systems to support project turn over * Reviewing GxP, GAMP, System Impact assessments, turnover packages (TOP), and standard operating procedures (SOP) * Presenting self-authored training material including overviews of UV/Vis and solution preparation validation lifecycle* Communicating weekly within teams to update project statuses, roadblocks, and paths forward

Contracted to Bristol Myers Squibb. * Coordinated weekly with a team of 3-8 upstream scientists to individually maintain process development experiments over the weekends* Ran Cedex samples for metabolite data and replaced materials according to Ambr15 and Ambr250 automated system requirements* Set up Tecan robot workstations and ran scripts for sampling and feeding processes* Sampled 20L rocking bioreactors and 200L, 500L Xcellerex single-use bioreactors for pH updates, metabolite samples, retains, and feed calculations for the 200L, 500L tanks

•Developed the hydrophobicity of polymer solutions to characterize transition temperature•Conducted dynamic light scattering (DLS) and ultraviolet visual (UV-vis) spectroscopy experiments to identify transition temperatures and confirm absorbance differences between polymer solutions•Prepared samples via pipette and centrifuge•Cell cultured human dermal fibroblasts (HDFs) and human umbilical vein endothelial cells (HUVECs) •Collaborated with a growing team of researchers to draft a scientific article for future publication and presented summary posters on 4 occasions•Communicated future research goals with faculty advisor and graduate students on a regular basis

•Developed soft skills including communication and teamwork in a fast paced environment while providing premium customer service

•Researched COVID-19 viral vector vaccines and corticosteroid therapeutics via online resources•Partnered with a team of 5 fellow scholars to synthesize a cohesive presentation for community members•Presented to the NH community through the 'Making Sense of COVID' virtual symposium (26 February, 2021), and to fellow researchers during the NH-INBRE annual meeting (9-10 August, 2021).

Bachelor Of Science - Bs, Bioengineering

Activities and Societies: Tau Beta Pi (TBP) Honors Society, International Society of Pharmaceutical Engineers (ISPE), Biomedical.

Associate'S Degree, Bioengineering And Biomedical Engineering

Activities and Societies: STEM Club, Phi Theta Kappa

Education record