Alex Crone, Ms, Mba, Pmp Email & Phone Number

Boston, MA, US

• Global manufacturing operations and lifecycle management for CASGEVY™ (exa-cel), an autologous, ex vivo CRISPR/Cas9 treatment for patients with severe sickle cell disease or transfusion-dependent beta-thalassemia
• Project management for operational governance forums across critical components and drug product CMOs
• Created and maintained Smartsheet project management dashboards with forms and reports for KPIs across QMS and batch disposition to support operational excellence, strategy, and business operations
• Operational excellence six sigma green belt project to improve the end-to-end business process for quotes, statements of work, purchase orders, and invoices across the supplier network

Boston, MA, US

BIOT5631: Cell Culture Processes for Biopharmaceutical ProductionBIOT6320: Quality Management Systems and ValidationBIOT6320: Design and Development of Biopharmaceuticals

Billingham, GB

• Client-facing MSAT lead for Commercial Validation of both Upstream Fermentation and Downstream Purification through CPV, APQR, and Campaign Summary Reports across five programs
• Implemented QMS: Deviations, Investigations, Change Controls, and CAPA to consistent, effective, on-time completion

Raleigh, NC, US

Durham, North Carolina, US

• Client-facing MSAT lead for 16 clinical/PPQ technology transfers to cGMP downstream manufacturing of mammalian fusion proteins, antibodies, enzymes, and vaccines
• Integrated facility fit calculations: scale-up/down; time & cost estimates; client scale decision meetings; equipment, solution, and raw material requirements; and PFD generation
• SME and Qualified Trainer for UNICORN and QMS

Durham, North Carolina, US

Fun fact: blindside hit by some teddy bears during the holiday season charity teddy bear toss

Woburn, Massachusetts, US

• Developed pilot-scale end-to-end Integrated Continuous Manufacturing "ICM" and increased API drug load from 50% to 80%
• Solved powder accumulation problem in feed hopper by implementing a timed vibration system to improve safety and process performance
• Acknowledged in two journal articles for modular, end-to-end continuous manufacturing (attached)

Waltham, MA, US

Upstream and downstream process development for novel biologics platforms, Tri-Specifc NK cell Engager Therapies “TriNKETs” and CYTOKINEs, through E. coli, HEK, and CHO cells

Developed process and formulation for gene therapy lipid nanoparticles through microfluidic mixing, tangential flow filtration "TFF," and lyophilization to extend drug product stability

Stoughton, Massachusetts, US

Produced and analyzed industrial cleaning products for sale

Developed curriculum and taught classes to Grade 6-8 students in Scratch, Web Design (HTML, CSS, JavaScript), Visual Basic, and Java

Ms, Chemical Engineering

Master Of Business Administration - Mba

Bs, Chemical Engineering, Minor In Biochemical Engineering

Business Administration, Management And Operations