Cambridge, Massachusetts, United States
Exceedingly driven, collaborative, and adaptive process engineer motivated by a passion for advancing therapies which directly impact patient lives. 5+ years of experience in the CGT space specializing in process development, characterization, validation, non-viral delivery, and IND/BLA-enabling activities. Skilled in supporting technology transfer and CMC deliverables, building and optimizing scalable clinical manufacturing processes in fast-evolving environments, and communicating effectively across cross-functional teams. Versatile and detail-oriented, passionate about mentorship and community, and adept at managing concurrent projects committed to driving company goals and helping patients in need. Outside of biotechnology, I’m especially passionate about community building and working with children. I am the creator and founder of LonelyBones Skate Collective, a Boston organization dedicated to making skateboarding and rollerskating a more accessible space for women and gender non-conforming folks. I also spend my free time as Head Age Group coach for Revolution Aquatic Club, an elite swimming organization I helped found. I’m a people person through and through, and I am passionate about bringing that skill set to the biotech space!
- Facilitated process development, clinical and commercial technology transfer, risk assessment, process characterization, and BLA-enabling activities for EDIT-301, a CRISPR-based ex vivo gene therapy for the treatment of sickle cell disease and beta thalassemia - Spearheaded development and scale-up of closed system media preparation including custom material design and sourcing, workflow development, batch record writing, design and execution of stability studies, and risk assessment - Developed and optimized thaw and administration process for EDIT-301; supported successful release and infusion of over 30 patients and personally traveled to clinical sites to support DP infusion - Organized process-related FMEAs and comparability studies and authored process characterization master plans to support process control strategy development and process validation - Led cross-functional investigations for critical deviations, OOTs, and OOSs pertaining to DP release panel - Authored, reviewed, and provided technical expertise during the preparation of CMC-related regulatory filings - Generated data to support IND and BLA-enabling activities including toxicology, reference standards, assay qualification, lead stability, forced degradation studies, and engineering runs
- Led coordination and execution of over 50 investigational process studies to validate and optimize equipment performance and achieve production of viable drug product via the novel Closed Aseptic Manufacturing System (CAMS), which aimed to bring SQZ’s lead cell therapy to the patient’s bedside - Authored SOPs, batch records, risk analyses, ELNs, and CAD drawings critical to driving the CAMS through software, hardware, and disposable kit design; system build, development, validation, and technology transfer - Oversaw all long-term collaboration with and timely completion of project deliverables by external vendors, manufacturers, service providers, auditors, and consultants - Traveled to CMO as process SME to support manufacturing operations, technology transfer, and operator training - Managed a team of 3 interns/co-ops
- Assist experiential learning advisors in the Bioengineering and Chemical Engineering departments at Northeastern University with helping underclassmen successfully navigate the co-op application and acceptance process - Mentor students with resume reviews, mock interviews, and job search advice - Lead Q&A sessions to familiarize underclassmen with the NUworks co-op database - Formulate and compile job listings on Northeastern's career platform, NUWorks - Maintain logistical and administrative responsibilities: syllabus writing, NUWorks report generation, student, staff, and employer record-keeping