Michelle Satchell Email & Phone Number

Boston, Ma, Us

New York, New York, Us

Pfizer acquired Wyeth in late 2009. I work in the Cell Bank Suite (CBS) providing clinical and commercial cell banks for both Phase I - Phase III as well as commercially licensed products.Lead Scientist within group with increasing responsibilities in cell banking process improvement and quality management systems. Work with senior management of all cross functional support groups to ensure group is compliant with updated cGMP, regulatory and internal requirements. Increase group productivity through implementation of Operational Excellence (OE) initiatives. Qualified a component used in the cell banking process (i.e. performed experiment, interpret the data and presented to cross-functional group of peers and management).-Manage cell banking activities including vial thaw/culture inoculation, culture scale-up, vialing, storage, purity, sterility and stability testing-Execute process improvement by analyzing and incorporating an automated cell counting device (Cedex HiRes) and temperature shipment tracking device (Shipslog data logger) for use in the cell banking procedure-Prepare all required information to support cell bank disposition (i.e. ensure all investigations are closed, obtain settling plate results, and obtain manufacturing formulation records)-Manage validation activities (i.e. review and approve URSs, IQs/OQs/PQs and summary reports)-Write and review test methods, SOPs, CAPAs, master batch records, technical reports and memos using Electronic Document Management System (EDMS)-Perform Cell Banking training to develop junior personnel and other group members-Participate in site quality audits to ensure GMP and Quality System Regulations compliance-Evaluate suppliers and maintain records for laboratory equipment and supplies using the SAP ERP system -Developing a harmonized purity testing paradigm between Andover and St. Louis sites

New York, New York, Us

Experienced Quality Control (QC) professional working in a cGMP mammalian Cell Banking Suite. Responsibilities include: manufacturing master and working cell banks, storage, maintenance and inventory of cell banks, purity and sterility testing, cell bank stability testing, creation of manufacturing batch records, validation of new equipment (Cedex HiRes, ShipsLog data logger and others), present scientific data to cross-functional group of peers and management, provide audit support for both internal and external auditors and ensure that the Cell Banking Suite is compliant with all required regulations. Other experience includes specializing in competency-based training.

New York, New York, Us

Developed and maintained instructional design training programs (Maintenance and Work Request procedure, Determination of Cell Density/Viability and others). I communicated recommendations on changes to the training processes and programs. All previous Training Specialist I responsibilities remain the same including: -Communicated training metrics to Sr. Management-Partnered with Manufacturing, Validation, Engineering, and Quality departments to identify learning objectives-Utilized evaluations, metrics, and surveys to determine program effectiveness-Audited training records to ensure compliance with the Code of Federal Regulations (CFR)-Coordinated training sessions as required to close any learning gaps

New York, New York, Us

Used the adult learning concept to develop and design training programs (Train the Trainer, Documentation Practices, ISO Class 5, 7, 8 cleanroom gowning and others). Lead development trainer that managed the IsoTrain database for the development group (enter curriculum courses, revision updates and training session record). Identified technical training problems and developed solutions. Planned and prioritized concurrent assignments/activities with minimal supervision.-Managed over 100+ department personnel curriculum and training requirements-Conducted training sessions for multi-disciplined personnel-Reviewed metrics to ensure compliance with training requirements-Created periodic reports to inform management of training progress-Performed need analysis evaluation (i.e data collecting, findings, conclusions and recommendations)-Maintained personnel training files (update with resume, personal profile, equivalency and curriculum reports)-Managed Local book (notified group of new or revised documents and updated files)

Lead trainer within group to develop and manage competency-based training program. I performed Instructor-led and On-The-Job training sessions to support production requirements. Communicated with Sr. management any learning gaps and metric analysis.-Maintained training records for the department-Wrote, reviewed, and revised SOPs and MBRs using the Documentum system -Reviewed and maintained equipment usage and maintenance records-Maintained and submitted equipment purchase orders

Hands on experience with aseptic technique, cell culture, media preparation and manufacture of the regenerative medicine. Developed, updated, and reviewed standard operating procedures (SOPs), manufacturing batch records (MBRs), CAPAs and technical reports. -Performed GMP Best Practices during manufacturing of product-Lead Associate to track, order, and maintain inventory of production supplies -Independently trained new and current personnel on laboratory activities

Utilized learned cGMP rules and regulations. Gain knowledge on investigation process and quality management systems (i.e. change controls, deviations and CAPAs). Performed laboratory testing to confirm raw materials meet release requirements of incoming and outgoing raw materials.-Supported Cell Culture maintenance, Environmental Monitoring (EM), Bioburden, Gram Stain, and Growth Promotion testing-Completed ELISA assays, Gel Electrophoresis and Western Blot analysis