Manuela Valencia

Tour of duty with the Cell Therapy Development and Operations team:

• Develop high-quality technical documentation for future AI query tool usage.
• Leverage AI-driven platforms to streamline writing.
• Collaborate with cross-functional teams to gather information and ensure documentation meets all requirements.

• Lead CMC writer for a Biologics License Application (BLA).
• Author and review Modules 2 and 3 for commercial CMC submissions; develop authoring plans and coordinate cross-functional input.
• Manage logistics for regulatory filings (e.g., BLA, MAA, NDA, PAS, CBE-0/30, Variations, HA queries); while interface across the BMS network.
• Ensure CMC content aligns with regulatory requirements and health authority expectations.
• Lead submission reviews, drive consensus, and manage draft finalization.
• Oversee data verification to ensure compliance with SOPs.
• Support standardization efforts through data verification initiatives.

• Led the method trending program and statistical data analysis, managing risk-based action planning and high/medium/low risk investigations across multi-disciplinary teams.
• Conducted analytical performance reviews for APQR, including method invalid rates and OOS investigations, while authoring and revising SOPs and technical documents.
• Collaborated with cross-functional teams to support data analysis requests and improve trending systems, contributing to knowledge sharing and best practices.
• Participated in audits and maintained proficiency in Discoverant, Sample Manager, LES, Infinity, Empower, and SAP.

• Conducted routine and non-routine testing in a GMP environment, utilizing techniques such as endotoxin testing, bioburden analysis, and environmental monitoring.
• Analyzed test data, authored lab investigations and exception reports, and revised procedures to enhance lab operations.
• Managed sample receipt, shipping, and storage, while utilizing LIMS for efficient sample management.
• Supported audits, including serving as a translator during a Mexican health authority audit, and performed data trending to ensure assay performance.

• Generated Environmental Disturbance Reports and coordinated follow-up meetings to assess CAE event impacts, while executing environmental monitoring (particle count, microbial, air velocity).
• Created and modified controlled documents, including technical reports and non-conforming material reports, and provided technical support for environmental monitoring issues.
• Supported audits (FDA, BSI, internal), coordinated sterilization cycle validations, and conducted quarterly audits of gowning and cleaning practices.
• Trained new personnel on gowning procedures and maintained accurate records of lab procedures and results, while liaising with management and external vendors for testing needs.

• Conducted visual, dimensional, and functional inspections according to established policies, utilizing various test and measurement equipment (e.g., Vernier, Caliper, Optical Comparator).
• Collected and analyzed data for First Article inspections and developed recommendations for changes to inspection procedures and policies.
• Maintained proficiency in SAP for managing incoming material QC requirements.

• Supported the Microbiology department through monthly cleanroom testing and assisted in data gathering, analysis, and trending.
• Contributed to validation and qualification activities, including dunnage load construction, and provided input on procedural changes for manufacturing efficiency.
• Studied relevant standards such as ISO 11135 and ISO 14644 to enhance understanding of sterilization and cleanroom practices.

• Performed assembly and inspection of Optical Coherence Technology (OCT) catheters in a cleanroom environment, ensuring compliance with FDA cGMP documentation.
• Maintained equipment calibration and preventive maintenance, documented environmental conditions (differential pressures, temperature, humidity), and provided input for process improvements.
• Trained new and lower-skilled operators on procedures and best practices.