L. Andrew Ramirez Email & Phone Number

Lebanon, Nj, Us

Lawrence Township, Nj, Us

Lead a cross-functional team, playing a pivotal role in supporting the lifecycle management and business operation of digital technologies and automation systems (e.g., Manufacturing Execution System, Automation Systems, Labeling Solutions, Reporting technologies, etc.) used to produce personalized cell therapy products at a 24x7x365 Manufacturing Cell Therapy site.Support the design, build, deployment, validation, and support of GMP automation and execution systems (Delta V, Syncade, MES, eBR, OSI Pi Data historian, Bartender, etc.) in a regulated manufacturing environment.Direct and oversee the MSEO functions accountable for manufacturing systems' operations support, systems engineering, automation, labeling operations, and lifecycle (change and release, including validation).Play a critical role in leading, organizing, and integrating Site and Global Technical Operations/MSAT teams and the Cell Therapy Global Manufacturing network at Bristol-Myers Squibb.• Manage, mentor, and develop the MSEO leadership team. Lead as a change agent to promote flexibility, creativity, and accountability.• Work with key partner organizations such as Manufacturing, Quality, Supply Chain, Information Technology, Facilities and Engineering, and PMO to build and maintain efficient systems that support the safe, successful, and compliant startup, technical transfer, and operation of a clinical and commercial Cell Therapy manufacturing facility.• Site Manufacturing Execution System Business Owner (process and system). • Develop and employ strategies to bring alignment and genuine partnership between business owners, IT, Quality, network, site, and global partners.• Partner with the PMO Associate Directors/Director to facilitate an effective, cross-functional governance process to enable portfolio status and health.

Lawrence Township, Nj, Us

Led the successful business integration, deployment, and optimization of NextGeneration Manufacturing digital technologies into commercial CAR-T Manufacturing sites.Responsible for managing activities and personnel associated with design, development, delivery, validation, change management, maintenance, and support of site manufacturing execution system (MES) and associated boundary systems (GPS, ERP, LIMS) across multiple clinical and commercial cell therapy manufacturing sites.Accountable for leading personnel responsible for Operations Support and business process automation projects in a cross-functional and collaborative environment.As a leader in the Process and Technology Department, I had the opportunity to maintain and implement site and global policies aligned with integrated corporate processes and in compliance with site, global, and industry standards.In addition, I led the team accountable for delivering and maintaining validated technologies suitable for commercial pharmaceutical manufacturing.

Leader of a digitally eclectic, results driven, and diverse powerhouse team, responsible for supporting day-to-day Computer Systems Change Management, Validation (CSV), Manufacturing Execution System (MES), SAP, and top priority technology projects and initiatives for Global Operations teams (manufacturing, quality control, validation, calibration, digital office, etc.).- Develop and support team members and mentees by coaching, training, feedback, clear communications, and providing/facilitating opportunities for development.- Connected Plant and Operations Technologies Site lead, enabling Digital Transformation across a Global and technologically diverse digital landscape.- SAP Manufacturing and Shop Floor Business Process Lead - Participate and contribute on Global Teams across multiple business disciplines.- Responsible for reliable and efficient team operations to support Global Operations.

Lead the assessment, development, and implementation of business solutions. Strategic and integrated business development.Business Continuity Management Program - BCM Team LeaderGlobal Manufacturing Execution Systems (MES) Program- Site Lead.

Manage, assist, and lead the integration, development, and implementation of software based systems to business processes for small to large scale projects. Reporting of Corrective and Preventive Action (CAPA) cases CAPAs and nonconformance for regulatory agencies, customers, and internal use.Subject matter expert for CAPA and nonconformance processes and databases, working closely with MS Office applications, SAP, and Trackwise Administrators for system improvements and upgrades.Responsible for compliance assessments of quality processes and systems.Internal audit team member – Collaborate in the completion and documentation of internal audits.

Product ReleaseTechnology SME

Pharmasuite Mes Versions 8 And 10, Manufacturing Excecution Systems - Pharmasuite

Bachelor Of Science (B.S.), Biomedical/Medical Engineering

Education record

Education record

Education record