· Led the development and implementation of Planisware, including UX design, significantly enhancing project management capabilities. Oversee the system's daily administration and facilitate user adoption across the organization.· Facilitated change management activities including establishing strategic goals, stakeholder engagement meetings, performing impact assessments, executing communication plans across business units, and initiative implementation.· Directed the creation of SOPs for all business processes within the research centers, ensuring consistent adherence to best practices across the organization.· Actively collaborate with subject matter experts (SMEs) across multiple disciplines to gather, verify, and incorporate technical and operational information into documentation. This process includes translating complex technical concepts into clear, understandable language for diverse audiences.· Direct the creation and selection of illustrative materials to complement technical documents. Work closely with graphic designers and technical staff to choose appropriate drawings, sketches, diagrams, and charts that enhanced comprehension.· Implemented rigorous quality review processes for all technical documentation, ensuring accuracy, relevance, and clarity. · Provide comprehensive editorial support to management and professional staff, contributing to the preparation of materials for publication or presentation.· Utilize a variety of tools and platforms to manage documentation workflows, including Microsoft Office Suite for document creation, SharePoint for document storage and organization, and Microsoft Teams for collaboration and communication with project teams.· Develop and maintain strong working relationships with all project stakeholders, from technical teams to management, ensuring alignment of documentation objectives with project goals and business strategies.

• Directly manage a team of approximately 15 multidisciplinary scientific professionals in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. • Plan, direct, and implement improvements in systems, processes, and procedures to increase efficiency, productivity, and quality. • Provide technical and regulatory consulting to internal groups and external clients regarding a broad spectrum of programs. • Competencies include knowledge, interpretation, and compliance for regulatory guidelines, agencies, and systems including USP, EP, JP, cGMP, ICH, and FDA. • Adjust revenue projections based on client timelines and resources, ensuring that projected revenue is recognized, and company quotas are met each month.

• Development and validation of analytical methods for raw materials and drug products. • Performed compendial testing for release, stability, development and validation of raw materials, drug substances, and drug products. • Writing and review of technical documents such as analytical reports (validation, stability, and quality control), scientific protocols, analytical methods, investigations, non-conformances, training documents, specifications, and standard operating procedures. • Managed client programs with minimal oversight. • Mentored and trained junior analysts. • Editing, standardizing, and updating materials prepared by other personnel to provide high quality documentation within client timelines. • Performed quality control/quality assurance review of documentation and data generated.

• Development and validation of analytical methods for raw materials and drug products with minimal oversight. • Performed compendial testing for release, stability, development and validation of raw materials, drug substances, and drug products with minimal oversight. • Writing and review of technical documents such as analytical reports (validation, stability, and quality control), scientific protocols, analytical methods, investigations, non-conformances, and specifications. • Mentored and trained junior analysts.