- Oversee analytics, reporting, and technical operations for Site Services Learning & Development (L&D).Monitor data flow for employee onboarding, transitions, and departures, ensuring accuracy in training requirements and operational reporting needs.- Proactively identify and escalate risks, driving actions to mitigate and resolve issues.- Perform innovative analytics, clearly communicating analyses and recommendations to diverse audiences.- Partner with Site Services stakeholders to identify process gaps and recommend improvements.- Fulfill ad hoc reporting requests, ensuring stakeholder needs are met.- Co-create the L&D process for ticket processing and service level agreements (SLAs).- Prepare documents and presentations for proposed technical/reporting changes, seeking consideration and approval.- Serve as the primary technical lead for L&D operations, including LMS, CMS, data, and analytics platforms.- Engage proactively with technical peers, the L&D team, and stakeholders to optimize operations and analytics.- Participate in cross-company technical teams to enhance enterprise learning systems and technologies.- Define actions required for planned outcomes and communicate effectively to stakeholders.- Ensure stakeholders are informed and proficient in utilizing enterprise tools for accessing and completing required training.- Create and maintain comprehensive project documentation to ensure business continuity.

- Collaborated with global, site, and departmental SMEs to manage curricula and training in the LMS, ensuring adherence to defined processes.- Guided SMEs in creating training programs using approved processes.- Supported vendor compliance training, maintaining process adherence.- Reviewed and approved training programs using approved templates.- Created, edited, and maintained training items for internal and external events.- Assisted in designing, developing, and testing e-learning content.- Provided mentoring and cross-training on e-learning tools for the team and business.- Tested and troubleshooted e-learning programs to enhance user experience.- Reviewed and approve corrective and preventive training.- Generated LMS reports for compliance, metrics, and business requests.- Monitored metrics to assess training assignment effectiveness and address deficiencies.- Led the annual curricula review.- Provided end-user support and refer technical issues to IT Support.- Supported IT Administrator in troubleshooting LMS system issues.- Assisted in assessment and testing for LMS vendor releases.- Performed testing for LMS configuration changes.- Supported internal audits and regulatory inspections.- Led global projects, ensuring effective management and on-time delivery.- Initiated/owned deviations, CAPAs, and change controls as needed.- Led continuous improvement initiatives to completion.- Supported other Quality Systems and projects as required.

- Created, edited, and maintained training items and associated quizzes in the Learning Management System (LMS).- Reviewed and approved training programs according to approved templates.- Supported documentation and creation of training items for information transfer and corrective and preventive training events.- Created, maintained, and assigned training curricula and user groups in LMS in partnership with Area Managers.- Verified training assignments for access to controlled areas and computer systems.- Entered training completions into the LMS.- Supported creation of training materials and content for areas as needed.- Coordinated training registration as needed.- Supported New Hire Orientation, including providing an LMS overview and scheduling onboarding training.- Partnered with IT to process new accounts/terminations in LMS for temporary staff.- Provided end-user support for LMS users and/or referred to IT Support for technical issues.- Assisted with LMS technical issues resolution in partnership with IT Administrator.- Supported upgrades and technical releases for the LMS in partnership with the vendor and other site LMS Administrators.- Supported testing for internal and vendor configuration changes.- Tested Computer-Based Training courses prior to assignment to ensure compatibility with end-user settings.- Understood how LMS interacts with other key systems.- Updated system-related procedures, work instructions, and training manuals as required.- Facilitated the annual (comprehensive) curricula review.- Educated end-users on LMS and associated systems and processes.- Generated training and metric reports as requested.- Provided timely and accurate support to third-party inspections and audits.- Reviewed and maintained departmental SharePoint content as needed.- Supported Quality Systems and Compliance projects as needed.

- Operated manufacturing equipment, executing routine and complex production processes in strict accordance with mandated Current Good Manufacturing Practices (cGMP) and Standard Operating Practices (SOPs) within company safety guidelines.- Supported GMP production operations within a CMO facility, utilizing groundbreaking gene therapy technology to provide safe and effective products to clients.- Performed manufacturing process operations, encompassing upstream (cell banking, inoculation, passaging, transfection, and harvest) and downstream (clarification, purification, and final filtration operations), utilizing bioreactors, column chromatography, purification skids, and Tangential Flow Filtration systems.- Conducted buffer and media preparation for these processes.- Contributed to process and document review, revision, and improvements.- Designated functional area training reporting within ComplianceWire LMS, assisted in identifying training gaps within the functional area, and created metrics to help the team monitor training and qualifications.

- Operated general manufacturing equipment in strict accordance with federally mandated Current Good Manufacturing Practices (cGMPs) and Standard Operating Practices (SOPs) within company safety guidelines.- Executed routine and complex production processes in a cGMP work area, supporting phase 3 clinical batching, design space studies, process development/engineering/validation runs, and ultimately commercial manufacturing of CVT-301 as business needs required.- Collaborated with QA Document Compliance, Quality Training, and Quality Systems team in restructuring MFG functional area curriculums to align with LMS go-live functionality and in preparation for PV engineering runs.- Reviewed and updated validation documents as required (URS, Design spec).- Identified major LMS go-live blockers and additional glitches within the system.- Contributed to the roll-out of Acorda Chelsea’s LMS, using previous knowledge of system prototyping and operational qualifications to help orient new training coordinators to the LMS.- Facilitated instructor-led training sessions for multiple departments to orient new end-users to site LMS.- Designated by management to represent GxP regulated functional area in activities related to training outlined in the GxP Training Program.- Coordinated functional area training activities, advised individuals within the functional area on issues related to training, and collaborated with QS training and area management on the development, implementation, and maintenance of relevant training initiatives and activities supporting our area functions.- Participated and contributed to LMS continuous improvements, representing functional area business needs and communication to/from the functional area to QS.- Supported process operations improvements through document revisions, red-lining of process procedures and MBRs, generation of work orders, and contributions to discrepancy reporting and investigations.

- Executed routine and complex production processes in a cGMP work area, supporting phase 3 clinical batching, design space studies, process development/engineering/validation runs, and ultimately commercial manufacturing of CVT-301 as business needs required.- Collaborated with Engineering, Facilities, Metrology, Quality Assurance, and Quality Control to troubleshoot manufacturing process system and equipment-related issues, meeting production scheduling goals and optimizing the process.- Assisted in the final packaging and inspection of pharmaceutical products.- Provided feedback to management on recommendations for procedural and process improvements.- Utilized process knowledge to influence positive change during the review and revision of standard operating procedures (SOPs).- Assisted in the development and implementation of improved work practices.- Supported process operations improvements through document revisions, red-lining of process procedures and MBRs, generation of work orders, and contributions to discrepancy reporting and investigations.- Designated functional area training coordinator for the spray drying team, responsible for managing extensive training curricula and training timelines and developing training materials to deliver to staff clearly and concisely.- Oversaw functional area training to ensure continuous compliance with training requirements for manufacturing staff.- Coordinated functional area training activities, advised individuals within the functional area on issues related to training, and collaborated with Quality Systems training and area management on the development, implementation, and maintenance of relevant training initiatives and activities supporting our area functions.- Assisted with building out the site end-to-end process prototype and validation testing for a soon-to-be-implemented automated learning management system.

- Operated general manufacturing equipment in strict accordance with federally mandated Current Good Manufacturing Practices (cGMPs) and Standard Operating Practices (SOPs) within company safety guidelines.- Performed multi-step purification processes, starting with filtration, through 6 different chromatography operations in sequence, selectively isolating the protein of interest, and formulating the bulk replacement enzyme drug product Cerezyme®.- Maintained all associated documentation for operations being performed.- Reviewed and recorded physical inventory of stock items.- Adjusted the bulk product volume and formulation to meet drug dosage specifications.- Accurately performed work order component issues, in MFG/Pro, of materials used in manufacturing processes.- Created and submitted work requests into the EAM system for facilities maintenance, metrology, or automation engineering departments.- Performed routine preventative maintenance on system components.- Assisted with troubleshooting routine issues and defects.- Identified, escalated, and documented events that deviated from normal operations.- Brought deviations in process protocols to the supervisor's attention and participated as needed in investigations.- Assisted in the creation and revision of manufacturing documentation by providing input to the technical composition of documents.

- Performed a variety of complex tasks under general guidance and in accordance with current Good Manufacturing Practices (GMPs).- Prepared and operated process equipment in support of large-scale chromatography systems.- Conducted clean-in-place and steam-in-place operations to prepare equipment for manufacturing operations.- Demonstrated a solid understanding of GMPs and how they applied to specific responsibilities.- Followed accurate oral and written procedures in operating production equipment and performing processing steps.- Maintained orderliness in the process area.- Stocked the production area with supplies required for bulk manufacturing processes and activities.- Monitored operations to ensure compliance with process specifications.- Practiced safe work habits and adhered to the company’s safety procedures and guidelines.

The Zhang laboratory combines genetic, molecular approaches with behavioral analyses to study the function of neural circuits and the regulation of behavior in Caenorhabditis elegans, a genetic and genomic model system.- Supported and ensured laboratory compliance with established GLP and/or GMP procedures.- Acted as the primary contact for day-to-day lab activities, including medium preparation for the growth of c. elegans and bulk reagent production for molecular biology and genetic experiments.- Handled ordering and receiving of laboratory supplies and chemical reagents, as well as the preparation of media and buffers.- Maintained c. elegans strain collections and database.- Participated in team research projects and assisted with experiments.

The Department of Anesthesiology, Perioperative and Pain Medicine at Brigham and Women's Hospital is involved in laboratory and clinical research at the forefront of academic medicine. The mission of this research is to understand the mechanisms of disease that underlay the causes and conditions during and after surgical anesthesia and other operative procedures, and to apply this understanding to develop new and better treatments and thus to advance the clinical practice of anesthesia.- Conducted functional platelet analysis on blood samples collected from study patients.- Tested platelet function using multichannel platelet aggregometer systems.- Determined platelet receptor counts on resting and activated platelets using monoclonal anti-human antibodies and thrombin receptor-activating peptides.- Calibrated FACSCalibur flow cytometer using non-fluorescent particle-sized calibration standards to ensure accurate data collection and analysis.- Quantified and analyzed platelet surface receptor expression using flow cytometry.- Collaborated closely with the head of the study to perform statistical analysis of data.- Assisted in maintaining transgenic mouse colonies.- Compiled and maintained a well-organized and detailed laboratory notebook.

• Acted as resource to new students and families• Provided a welcome and supportive orientation experience to incoming students• Prepared information packets for incoming students and parents• Helped in implementing and coordinating events for each session