Trained in GMP cell therapy manufacturing with direct exposure to CAR-T, TIL, and large-scale bioreactor systems. I’ve authored deviations, supported aseptic processing, and contributed to EM initiatives in fast-paced clinical and commercial environments. My foundation is technical, but my growth has been in systems thinking—aligning operations, quality, and people under real-time pressure. I’m now positioned for cross-functional roles where precision meets leadership.
Process Engineer|
Cartesian Therapeutics
From September 2024 to June 2025 • 1 year(s)
Led end-to-end CAR-T manufacturing operations in a fast-paced, GMP-regulated startup environment, executing autologous workflows in closed systems while driving process stability and executional alignment across teams. Spearheaded system-level training and documentation efforts to improve clarity, consistency, and cross-functional cohesion.
• Supported tech transfer and phase-based scale-up using GRex and Sefia systems in ISO-5 environments, adapting workflows across site and protocol changes
• Authored structured deviations and CAPAs, applying root cause analysis (5 Whys, impact assessments) to drive process clarity and compliance
• Collaborated with QA, MS&T, and QC to revise batch records, implement corrective actions, and reduce floor-level ambiguity
• Delivered targeted training on evolving workflows, developing system-based guides to improve operator consistency and protocol adherence
• Contributed to EM documentation and surface/air sampling strategy during classified operations to support batch release
• Identified recurring execution gaps and led development of One Point Lessons to standardize procedural responses across teams
• Known for reliability under pressure and ability to provide actionable insight during unstable or in-transition operations
Manufacturing Associate II|
Catalent Pharma Solutions
From May 2023 to August 2024 • 1 year(s)
Supported upstream manufacturing for large-scale biologics production, operating iCELLis bioreactors while maintaining tight control over all critical process parameters. Played a key role in maintaining batch integrity, supporting in-process testing, and coordinating with downstream partners.
• Operated iCELLis bioreactors, managing scale-up for upstream cell culture and maintaining pH, DO, and temperature within GMP specifications
• Conducted in-process testing to assess viability and productivity, contributing to downstream planning and product consistency
• Applied real-time decision-making to adjust conditions and resolve deviations in early-stage cell growth
• Utilized POD Millistack filters and a range of welders/sealers during closed-system processing for aseptic integrity
• Instrumental in the development and implementation of a 5S Kanban initiative to streamline material replenishment, reduce variability, and increase stockroom visibility
• Partnered with QA and MS&T to troubleshoot upstream challenges and maintain alignment with production targets
• Performed routine calibration and maintenance to minimize downtime and uphold equipment performance
Sr. Clinical Operations Associate|
Instil Bio
From July 2021 to February 2023 • 2 year(s)
Held a hybrid operations role at the intersection of clinical logistics and GMP execution. Managed tumor recovery coordination across North America and processed patient-derived material in ISO-5 cleanrooms. Played a central role in building onboarding pathways and instructional SOPs for cross-functional teams.
• Coordinated tumor recovery logistics and scrubbed into ORs across North America for clinical sample retrieval
• Processed tumors in ISO-5 suites using disaggregation and cryopreservation techniques under tight GMP/GTP timelines
• Created internal/external SOPs, designed visual training content, and led onboarding for clinical and GMP staff
• Supported environmental integrity through EM-aligned workflows during ISO-5 operations, helping maintain compliance during patient-specific tumor processing and cleanroom transitions
• Presented turnaround and contamination metrics to leadership; served as bridge between manufacturing and clinical ops
• Authored SOPs and designed structured training modules, including visual workflows and instructional videos adopted company-wide
• Ensured compliance with FDA, HTA, GTP, and GMP requirements across all patient-handling workflows
• Played a central role in building onboarding curriculum for both GMP and clinical operations teams
Manufacturing Associate |
WuXi Advanced Therapies
From October 2020 to July 2021 • 1 year(s)
Executed TIL manufacturing at WuXi by processing resected tumors in ISO-5 environments, completing full batch record workflows and operating key equipment while contributing to deviation investigations and GMP compliance efforts.
• Performed TIL manufacturing from resected tumors in ISO-5 suites, executing full autologous workflows with batch integrity
• Operated LOVO, Sebra, centrifuges, and NucleoCounter for downstream processing and product assessment
• Contributed to deviation investigations and CAPA development alongside QA to uphold compliance and improve documentation
