Leigha Terry

Serves as CAR-T processing expert during hiring process using previous experience in cell and gene therapy to provide the best candidates slate and reduce time hiring managers are spending on hiring process. Handling with all roles in the CAR-T manufacturing facility including roles in manufacturing, quality assurance, quality control, warehouse, and engineering in a trust-based hiring model

• Meet with hiring manager to understand roles and responsibilities
• Create all job descriptions
• Post roles via Workday
• Review all qualified candidates and created candidate for hiring manager to review included digital interviews
• Conduct all technical interviews and provide notes to hiring manager with recommendations of the top 2-3 candidates
• Schedule all final interview with hiring manager

• Manage and lead T-knife´s US based cell therapy CMO operations.
• Create all training plans
• Act as a single point-of-contact to the CMO to ensure on-time and in-full deliveries of all agreed upon commitments.
• Working in collaboration with T-knife´s EU CMC team, direct tech transfer activities from T-knife's internal process development team and the EU based cell therapy CMO to the US based CMO.
• Ensure the use of GMP compliant materials and external services. Ensure suitable documentation is established, approved, maintained and strictly implemented, (including SOP's, manufacturing instructions, change controls, test methods, specifications, sampling instructions, manufacturing/testing/batch records, master service agreements, quality agreements (with quality), etc.) Frequently visit and maintain presence at the external partners' sites and build strong interdependent relationship with the Project.
• Participate in management reviews of process performance, product quality, and the quality management system.
• Responsible for management of the US external manufacturing budget.
• Provide experience and input into conceptual and basis of design documents for T-knife's internal cell therapy and viral vector manufacturing facility.
• Provide input into operational readiness estimates (headcount projections, budgetary estimates, timelines, etc.)

• Managed of training for 86 technicians.
• Developed a training curriculum and training plan for multiple departments, based on a 30/60/90-day plan. Senior Administrator for Learning Management System, updating documents and input training records.
• Tracking daily and weekly progress reports to ensure associates were up to date with training program.
• Provide calendars to managers and supervisors to track and execute training activities.
• Led the initial and annual re-qualification of all team members for filled vial inspection, including working with supervisors to schedule training, maintaining calendar to ensure team remains compliant on this critical process, providing all initial training, and completing and submitting all required documentation.
• Delivered and created On the Job training, instructor-led training, Web-based training, E-learning and New Hire Orientation for Manufacturing personnel.
• Visual Inspection Subject Matter Expert (SME).
• Site lead for Global Team: Visual Inspection of Parenteral & Particle Management (VIP2).
• Train associates on Visual Inspection including Filled Vial and Empty Vial Qualification and Requalification.
• Maintain the training status of all IG Filling and IG Packaging employees and communicate to supervisors to ensure the team within compliance, SABA and Veeva Vault.
• Developed and maintained training plans; Track progress and generate weekly training reports for missing requirements to ensure the department remains in a compliant state.
• Create and revised SOPs, Job Aids, OJTs Knowledge Assessments, and Skills Assessment documents to support the department.

• Supervised and managed a team of 8
• Created and implemented new Fill/Finish Department meeting all deadlines to allow filling of drug products to be completed onsite, including aseptic media fill, validation, operator qualifications, visual inspection for multiple product AAV platform (5 products) including X-Linked Myotubular Myopathy, Crigler-Najjer, Pompe, CASQ2-CPVT and Myotonic Dystrophy
• Managed technical operations schedule with interdepartmental coordination and communication
• Including production scheduling for Upstream manufacturing, Downstream Manufacturing, and Fill/Finish
• SME for AAV multiple product platform during FDA and QP audits
• Responsible for managing upstream, downstream and fill/finish task assignments
• Created and executed aseptic validation process for aseptic media fill operations and aseptic operator qualification
• Created and implement Visual Inspection Process and Qualification
• Created/Implemented all training plans which included, On The Job, Instructor led training, and E-learning for Filling Operation and AAV Upstream Operations
• Created all documents and Batch records for Filling Operations(Multiple AAV Drug Products and Placebo)
• Sourced all filling operations related material including vials, stoppers, caps, and assemblies
• Tracked KPIs for Drug Substance to Drug Product
• Executed IQ/OQ of filling equipment: Flexicon Filling Pumps, Watson-Marlow Peristaltic Pump, Semiautomatic Crimpers and Integra WestCapper
• Execute, initiation, and closure of deviations/QIR, Change Request, and CAPA including investigation, root cause, risk assessment

• Created all modules and on the job training for manufacturing (Upstream/Downstream/Fill Finish) for multiple product AAV platform production (5 products) including X-Linked Myotubular Myopathy, Crigler-Najjer, Pompe, CASQ2-CPVT and Myotonic Dystrophy
• Maintained training records and tracked re-qualification dates Lead on floor during manufacturing processing (Upstream/Downstream), responsible for issue resolution and troubleshooting on the floor and to properly escalate and communicate any issues that could impact processing  Organized Manufacturing Process Schedule based on doubling time of cell culture and time parameter stated in Batch Records to meets the non-clinical and clinic product needs
• Created Daily and Weekly schedules to easily follow activities for multiple lot, personnel assignment and forecasting material usage including media and raw material consumption
• Coordinating master schedule for manufacturing, QC, and QA
• Execute, initiation, and closure of QIR, Change Request, and CAPA
• Subject matter expert for processing and procedures in cell expansion, which includes training of processing specific manipulation with an emphasis of aseptic technique.

• Working of AAV platform- with X-Linked Myotubular Myopathy, Crigler-Najjer, and Pompe
• Started-up state of the art clinical/GMP manufacturing facility
• Developed and implemented new SOP and Batch Record to meet the needs GMP processing from Process Development protocol
• SME for Upstream Manufacturing with FDA and QP audits
• Created training plans and on the job training
• Executed tech transfer from Process Development to GMP processing
• Developed and implemented new SOP and Batch Record to meet the needs GMP processing
• Created product and process specifications
• Created daily, weekly, monthly, and annual schedule which helped the department achieve goals and successful meet deadlines
• Created Batch Records for Cell Expansion, Bioreactor Operation, and Harvest Filtration

• The primary responsibilities of a Cellular Production Associate are to support the production of cellular products for patients participating in clinical protocols in Phase I, II, III and transfer to commercial procedures in a cleanroom environment following applicable regulatory requirements
• Protocols include cellular therapy, cell culture, gene therapy and solid tumor/tissue therapy
• Managed and executed protocols, including XSCID and TIL
• Performed cell processing operations such as cell selection/depletion, expansion, stimulation, transduction, harvest, cryopreservation, and preparing patient infusions
• Completed required processing documentation including deviation reports, change control, product change over
• Assisted with updating training programs, trained new employees, and performed daily compliance check on training status
• Created Batch Records based on IND and laboratory notebooks
• Created new SOPs and revised current SOP
• Batch review.

• Worked with other Cell Processing Associates utilizing Good Manufacturing Practices during aseptic processing of clinical and commercial products using Standard Operating Procedures (SOP)
• One of few manufacturing operation associates to be proficient in final product packaging, apheresis acknowledgment, apheresis receiving, operating, batch record review
• Exhibited aseptic behavior in the process of both manufacturing and aiding other cell processing associates in the immunotherapy process of Provenge
• Exhibited precise aseptic behavior during gowning qualifications and regular shift duties
• Implemented Verifier Training program which improved the overall efficiency of production success.

• Handled all reservations (hotel, transportation, food) pregame and post-game meals
• Spearheaded all team fundraising projects to raise money for new uniforms and equipment
• Responsible for all goalkeeper training, fitness, and developmental plans
• Assisted with field sessions, scouting reports, and all team and goalkeeper fitness.