Manage the preparation and maintenance of labeling Company Core Data Sheet [CCDS], Target Product Label [TPL], and US Prescribing Information [USPI]) for assigned products, including marketed and investigational products.• Experience working with oncology and cell therapy therapeutic areas.• Contributes to and manages the preparation of selected new DCSI/CCDS/TPL/USPI content and format; perform team review of ex-US labeling as requested; contribute to and review Annual Reports and safety reports; review/approve artwork for US labeling.• Contributes to the development of labeling strategy for an assigned product or indication.• Supports DCSI/CCDS/TPL/USPI review, approval, distribution, and tracking; coordinate the generation and review/approval of US labeling in Structured Product Labeling (SPL) format; initiate artwork requests, archive labeling documents• Develops required regulatory skills and knowledge to demonstrate increasing familiarity with competitor labeling, CCDS/USPI requirements, and ex-US labeling.• Experience in global prescription drug labeling includes United States, EU, Australia, Canada, Japan, China, and Switzerland.• Experience leading and facilitating cross-functioncal labeling team meetings.• Contributes to the review and approval of labeling documents, implementation of CCDS information into country-specific labeling, and archiving of labeling.

•Supervised a team of process technicians that develop technical, engineering, manufacturing or health, environmental and safety (HES) standards/programs for the on-going operation and production goals of the organization.•Identified issues related to facility operations and works with engineering, quality, regulatory and maintenance to resolve issues•Developed detailed technical knowledge of the equipment and process operations. •Provided initial front line support for troubleshooting •Supervised a rotating shift team meeting all safety, GMP, and production goals•Made hiring decisions, coach employees, and conducts employee performance reviews

Responsible for supervising Validation Scientists and managing the staff to ensure that the expectations of the department are met or exceeded.•Supervised all phases of validation.•Determined validation project timelines and priorities.•Completed validations independently to ensure timeless with minimal disruption of production schedules.•Write new SOPs and modified current SOPs.•Responsible for protocol development, approval, execution, and reporting.

•cGMP Validation•Temperature Mapping •Writing and executing Protocols (IQ, OQ, PQ) •Writing new SOPs and modifying current SOPs.•Trained on Delta V, PLC, and BAS systems.

Maintain documentation in support of IT systems. Consulted with managers and directors to address documentation of business processes.Reviewed and evaluateed validation assessments for application systems/projects.Created system validation plans and validation summary reports.Wrote and executes test scripts.

Created Technology Transfer reports to assist the Validation Department with validation protocol generation, determining critical test parameters, and finalizing processes in preparation for commissioning and validation activities.

•Made vaccines for healthy children in Large Scale Purification, a class 10,000 environment •Techniques included: diafiltration, weighing out material, autoclaving, ultra filtration, and knowledge of pH and conductivity meter •Reviewed batch records before release to Quality Assurance