Manage and supervised a team of Quality Control Project Coordinators, providing guidance, training, and performance feedback to ensure timely and accurate completion of different program activities. Collaborate with cross-functional teams, including PD/ AD, QA, manufacturing, and external clients, to ensure seamless project execution and alignment with project timelines. Prepare and reviewed quality control documentation, including sample plans, specification rationales and CoA’s ensuring accuracy and completeness. Participate in internal and external audits, ensuring compliance with regulatory guidelines and addressing audit findings in a timely manner. Monitor and analyzed quality control metrics and trends, identifying opportunities for continuous improvement, and implementing process enhancements. Selected Contributions:• Successfully managed and coordinate quality control activities for multiple complex projects, ensuring on-time delivery and compliance with regulatory requirements.• Actively contribute to the development and implementation of training programs for quality control project coordinators to ensure consistent and high-quality work performance.• Quality Control Management, Project Coordinators, Regulatory Compliance, Team Leadership, Cross functional collaboration.

Project Lead, Method Transfer, April 2020 - PresentEngage team attending meetings with other leaders, keep the team focused on the project moving toward to reach the goal. Coordinate implementation, design and validation of new QC Incoming methods. Provide advance technical directions and develop method and analytical studies. Provide support to technicians. Coordinate implementation of new instrumentation/technology (Instron universal testing system) into the QC Incoming operations. Provides recommendations and monograph based on general data to write change request. Selected Contributions:• Coordinates the method implementation and special projects.• Review and approve, CAPA, Change Control and Risk Management related documentation.• Create Incoming QC SOPs, reports, protocols, and any other documentation needed during any piloting/validation process.• Review and execute validation protocols (IQ, OQ and PQ) and reports for accuracy and compliance with GMP’s, Regulatory Agency and Internal policy requirements.• Writes and reviews analytical method protocols and reports.• Managed employee training for all new recruits over six month period and offered continuous advice, guidance and mentorship on duties and best practices. • Successfully trained co-workers in new equipment, support method transfer using mixed reality (Microsoft HoloLens) technology

Coordinate Implementation, design and validation of new analytical methods. Provide advance technical directions and develop method and analytical studies. Provide support to laboratory technicians. Coordinate implementation of new instrumentation/technology (X-Ray Diffraction machine, dissolution bath, Texture analyzer, balance printers) into the laboratory operation Provides recommendations and monograph based on general data to write change request. Selected Contributions:• Review and execute validation protocols (IQ, OQ and PQ) and reports for accuracy and compliance with GMP’s, Regulatory Agency and Internal policy requirements.• Create Laboratory SOPs, reports, protocols, and any other documentation needed during any piloting/validation process.• Coordinates the analytical method implementation and special projects.• Writes and reviews analytical method protocols and reports.• Review and approve, CAPA, Change Control and Risk Management related documentation.

Responsibilities include: perform experiments, organize data and analyses result in order to support manufacturing and quality areas. Generate robust and reliable data and ensures that contract studies are in compliance with the respective protocol and applicable guidelines and regulations. Support of Non-Conformance Events with data obtained throughout the experiments. Work under GMP and GLP conditions.

• Teach General and Organic Chemistry laboratory courses.

• Responsible of health and safety compliance in the laboratories, of keeping reagents and equipment inventory and to give support to the academy staff. Handling of laboratory equipment such as UV-Vis Spectrophotometer, HPLC, TOC, Atomic Absorption, FT-IR, GC-FID, Fluorescence Spectrophotometer, and RAMAN Spectrophotometer.

•Main responsibilities include sample analysis required for Finished BULK Product, Fermentation and Cleaning in accordance with current GMP, Good Laboratory Practices and JP, USP, EP pharmacopoeias. Development and implementation of new protocols with moderate review and engage coworkers in scientific discussions while effectively experimental methods were transferred from literature to the laboratory with necessary modifications. Train peers in current and new immunoassay methods. Techniques used for sample analysis include ELISA (Enzyme-linked immunosorbent assay), BCA (Bicinchoninic Acid Assay), Bacterial Endotoxin, GC FID, Atomic Absorption and HPLC. Work with different equipment as balances, pH Meters, Digital Pipettes, Yokogawa Recorder, HPLC, Microplate Readers and Microplate Washers. Proficient in analytical data software such as StatLIA, ADMIN/LIMS, Soft Max, WinKQCL Smartlab, TrackWise, Empower and Darwin. Work in compliance with Standard Operating Procedures (SOP’s) and Health and Safety policies. Maintained laboratory reagents inventory and laboratory equipment and facilities housekeeping in compliance with CGMP’s. Actively participate in safety walk downs through laboratory areas using Safe Start guidelines to prevent and improve safety issues.