Latasha Lee

• Orchestrated knowledge-sharing sessions, enhancing team understanding of industry standards.
• Advised project teams, providing subject matter expertise to support product development.
• Reviewed and updated documentation to ensure compliance with requirements
• Mentored junior staff, improving their professional skills and expertise.
• Drive continuous improvement
• Provide leadership on shop floor
• PMX, Darwin

• Determined training objectives and monitor team performance to refine training methods and content
• Planned, scheduled, and supported daily Media/Buffer Prep, Weigh/Dispense production tasks to ensure schedule adherence while maintaining successful and GMP compliant execution with bioreactors/SUMS
• Facilitated additional manufacturing activities and process support with other manufacturing groups, MS&T, QA, Maintenance and Engineering
• Ensured timely execution and review of batch documentation and logbooks, initiation of deviations
• Supervised, coached, mentored, and trained 8-10 team members
• Managed shift transitions by coordinating with team members for effective handover of responsibilities
• Ensure staff maintain high level of compliance to procedures and quality expectations
• Root Cause analysis/troubleshooting skills/Manufacturing Floor support
• Batch record reviews/Deviations/In-process support
• Ensure equipment and manufacturing facilities remain in working order by overseeing production technician maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair per Blue Mountain maintenance system
• Author, train, review manufacturing procedures
• Utilized electronic batch records such as MODA, ASCTrac for material movement
• Collected samples according to established procedures to ensure quality control standards

• Led large-scale projects focused on operational excellence and safety enhancements
• Recognize issues and effectively solve major atypical process issues
• Root cause analysis/troubleshooting
• Author/Revise SOPs and BPRs
• Knowledge of process automation systems and advanced user of electronic business systems (PAS, BAS, PLCs, LIMS, SAP, Live Link)
• Handle biologically and chemically hazardous goods
• EM Monitoring and Submit Samples via GLIMS
• Prepared and steamed vessels for product transfers following strict sterilization procedures.
• Operate, set up and break down Filler/Isolator
• Initiate CIP/SIP in Delta V
• Collaborated Parts Wash/Autoclave activities to ensure sterility of components
• Ordered and staged materials and bill of materials for efficient production processes.
• Delegate task and provide subject matter guidance to team members with problem solving and teamwork
• Performed Hand-Off/Tier during shift changeover
• Create Triage for deviations
• Coordinate qualification and validation activities with maintenance/MS&T/Quality
• Coordinate equipment, training, and personnel resources on daily basis
• Served as a qualified trainer, providing guidance and instruction to team members on operational procedures.

• SME in Analytical, mammalian cell culture manufacturing, Dilutions, Cell Counts and Sampling, providing leadership to new employees, inventory maintenance, and equipment management
• Reviewed batch records, managed CAPAs, and authored deviations to ensure compliance and quality standards
• PSF-Pooling, Sonification and Filtration using skids, Filtered Cells/Harvested, Shell Freezing
• Performed clarification of viral bulk to remove impurities.
• SWS (Aseptic Manipulation) Seeding of Virus
• Sampling (Aseptic Manipulation) performed can drops, pump finished product into cans for transfer to shell freezing
• Monitored shell freezer temps, status, prepped cans for transfer
• Conducted environmental monitoring to assess contamination levels in production areas.
• Cross-train and Trained new employees
• Maintained inventory using SAP, conducted material decontamination, and facilitated transfer processes

• Media filling/ Formulation
• Autoclave
• Filling
• Managed warehouse operations for efficient inventory control and distribution.

• Operated compression equipment to produce high-quality tablets in alignment with production targets
• Executed SOPs and GMP guidelines to ensure compliance and quality control in production processes
• Developed formulations to meet product specifications and enhance performance
• Executed coating processes to ensure optimal product quality and compliance

Executed SME manufacturing processes

Conducted quality review of batch records to ensure compliance and accuracy

Provided in-process support during production

Solid Dose

• Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
• Performed thorough inspections of incoming materials and outgoing products.
• Performed tests and inspections to conform to established standards.
• Evaluated samples against standards by completing measurements, visual inspections, and other established tests.
• Maintained quality documentation and records for conformance with relevant standards.
• Developed and implemented procedures to meet product quality standards.
• Collaborated with production staff to improve processes, reduce defects and optimize quality.
• Led root cause analysis to identify issues and propose targeted solutions.