IMCLONE SYSTEMS INC.
Logistics Specialist III (2010-Present)
Project managed critical study milestone activities, expiry updates at the global depots by managing tasks, timelines & communication with clinical supply planning, clinical development, quality assurance product development, strategic sourcing, procurement & external vendors. Orchestrate logistics of clinical drug research and development efforts, including concept, development, and packaging to maintain drug supply on a global scale.
- Partnered with clinical operations team to forecast supply requirements for protocol designs, drugs accountability, and monitor global inventory levels.
- Provided project management support for the creation & implementation of TEMPS (Temperature Excursion Management Processing System).
Project Coordinator (2006-2010)Contributed to effective manufacturing operations management by collaborating with interdisciplinary teams and applying project management principles to oversee project planning, sequencing, scheduling, monitoring, executing, and completing projects in alignment with outlined goals. Developed and communicated project objectives, documented milestones, maintained schedules, and updated stakeholders.
- Spearheaded the design, development, and deployment of LIMS. Streamlined and standardized processes across three manufacturing facilities.
- Supervised daily activities of manufacturing sample lab and maintained cGXP compliance.
Regulatory Affairs Coordinator (2005-2006) / Clinical Affairs Consultant (2004-2005)Oversaw the preparation of investigational new drug (IND) submissions to the FDA; gathered, documented, and processed six clinical research projects. Collaborated with document publishing vendor, clinical researchers, internal teams, and senior management to deliver high quality results within tight deadlines.
- Evaluated criteria, redesigned processes, and standardized protocol of compiling and reviewing clinical site documentation for regulatory authorities, improving the overall quality of FDA submissions.
- Coordinated the review and start-up of two clinical monoclonal antibody pipeline study's documentation by interfacing with regulatory and clinical affairs project teams.
- Facilitated the refilling and subsequent approval of Erbitux, treatment for Squamous Cell Carcinoma of the head andneck, which improved corporate reputation.