Cell Therapy CDMO

Buffer & media / transduction / cell bank expansion /  formulation / fill / finish / packaging and labeling operations of red blood cell therapeutics. Responsible for the quality assurance of red blood cell therapeutics (RCT) in clinical phase I/II clinical trials.Primary responsibilities performing batch record review, raw material disposition, visual inspection, product changeovers, Gemba walks, internal audit response, and department document revisions. Author/owner, review, approve, and/or implement tasks for the following items:• Environmental Monitoring Memos and Quarterly Reports• Deviations (Levels 1, 2, 3): contamination, EM excursions, automation issues, MFG issues, visual inspection, etc.• Corrective and Preventative Actions (to above deviations, internal audit response, etc.)• Change Controls (scale-up, specification updates, visual inspection/particulate matter, etc.)• Documentation Updates: Quality Assurance, Quality Control (EM), Manufacturing, Tech Transfer, etc.CAPA Owner for internal audit response to batch record review and disposition process. Authored or assisted with review/approval of documentation to remediate observations.Change Control Owner of major revisions to the visual inspection program and particulate matter investigation/remediation process reflective of FDA Guide (draft Dec 2021).

Business established to provide standard QA services (operations, validation, auditing) for the pharmaceutical or medical device industry via C2C contracts. Business founded in August 2019; incorporated as limited liability corporation on August 2021. Services: QA Operations (batch record review, OTF activities, raw material and finished product disposition, etc.):• Buffer / Media / DS & DP Formulation • Sterilization Cycle Records• Cell Culture Expansion• Fill (Isolator/RABS/ISO 5 Cleanroom/BSC)• Finish (Liquid/Lyophilized)• Packaging and Labeling Audit ResponseQuality TrainingQuality Records (QE, CAPA, CC)Quality Risk Management (QRM)Technical / Policy WritingDrug Product Types:Live Virus, Solid/Oral Dose, Liquid and Lyophilized Products, Gene & Cell Therapy, Liposomal ProductsGeneral Regulatory Compliance Auditing Services (21CFR§11, §210, §211)Quality Assurance Validation Engineer (QAVE) Services: • Tech Transfer• New Drug Product Implementation• Equipment Qualification• Integrated Line Testing• Process Validation• Computer System Validation• Periodic Reviews / e-System Reviews• Risk AssessmentsClients:• Gilead Sciences (2019-2020)• Rubius Therapeutics (2021-2022)

• Responsible for the quality assurance of various medical device endotoxin test kits, standards, etc. with tasks including the following: batch record review, visual inspection, test kit assembly inspection, Gemba walks, etc.• Observe critical manufacturing process steps, clean room behavior and adherence to defined process parameters by performing walk-throughs of production and support areas.• Initiate project to revamp visual inspection program. Assess applicability of regulatory requirements (USP, JP, EMA, WHO) and guidance documents (PDA) to medical device products. Construct visual inspection program utilizing ISO 13485:2016 and ICH Q9 risk management principles; program revised for appropriate medical device application. Generated FMECA to assign defect classifications and record failure modes. Implement feedback loop to assess new defects or reprocess using MFG control limits, submit new defects and particulate matter samples to Technical Support (TS), and attach TS evaluation memo with batch record. • Initiate revamp to safety for fill/finishing processing. Propose short-term/long-term changes to reduce lifting during processing (up to 80%).• Initiate a 6S project on manufacturing mechanical chase; track tasks, due dates, and progress.

• Responsible for the quality assurance of a CMO fill/finish of live virus vaccines. Review issuance of BPR, review various logbooks (EM QC/MFG), perform pre-use area line clearance of filling suite isolators (oven/autoclave and lyo interfaces, transfers, filler, capper, and acculumator) and lyophilizer/biosafety cabinets. • Review batch production records for aseptic filling, visual inspection, and labeling & packaging operations: filter integrity tests, clean-in-place, vaporized hydrogen peroxide cycles, leak tests, glove/half-suit integrity test, dry heat/depyrogenation cycles, lyophilization cycles, environmental monitoring data packets.

• Responsible for quality oversight of all nine packaging lines and all chambers between two facilities (La Verne/San Dimas). Responsible for the installation, qualification, periodic records review, and requalification. • Assisted with ten new drug product launches in 2020 for the following: oral pellet medications to cure pedatric patients with hepatitis C, solid dose rheumatoid arthritis/inflammation medications, and the first COVID-19 therapeutic, Remdesivir.• Support the quality risk management (QRM) program through initiation of risk assessments. Initiate and/or update failure modes, effects, and criticality analysis (FMECA) for all packaging lines. • Author or review/approve, as applicable, quality/manufacturing/engineering/validation documents for QA/MFG operations, design specifications and engineering assessments, and qualification paperwork (protocols/final reports/protocol exceptions).

• Perform in-process acceptable quality limit (AQL) sampling, batch record review, and support disposition/document archival activities: solid dose, vial inspection, vial packaging, and manual packaging lines (Britestock and labeled product). • Revise/Author standard operating procedures (SOPs), AQL inspection forms, batch record review checklists, manufacturing production records (MPRs), bill of matierials (BOMs), Risk Assessments (RAs), grandfather training memos, and quality master plans (QMPs). Create new training curricula for QA AQL inspectors using critical items checklists (CICs), theory documents, and theory exams.• Review engineering lifecycle documents to support initial design or validation activities, as applicable. Review and approve various stages/combinations of validation protocols (i.e. IQ/CQ/OQ/PQ); executable test scripts and final reports, respectively). Review process performance qualifications (PPQ) and/or process validation (PV) protocols and final reports. • Review and approve protocol exceptions and follow-ups for protocol generation errors, changes to test scripts and/or specification documentation, and authorize additional testing, as needed. When appropriate, authorized the leverage of test scripts from commissioning to fulfill some validation requirements. • Review and approve requirement trace matrix and computer system assessments (FDA Part 11/EU Annex 11). Review release checklists (pre-commercial change management) to prepare for the release of area/process for routine usage.

• Managed a small group of quality control employees, lab equipment, continuous improvement projects, documentation, and lab consumable inventory for California's largest recycled post-consumer food grade plastics (PET) manufacturer.• Create and/or rewrote the entire library of work instructions (over 40 documents) for the QC team. • Complete time study on all quality team individuals / processes to establish SMART goals. • Implement additional safety engineering controls.

• Support clinical packaging and labeling operations of active/placebo drug products (vials, capsules, syringes) and various medical devices (automated/manual injection pens). Ensure compliance for thousands of different configurations, numerous products, and destinations.• Perform AQL sampling, primary and secondary label artwork approval, batch record review, expiration date assignment, audit label inventory, collect/maintain reserve samples, and perform material transactions. • Assess risk of study unblinding of blinded clinical studies via comparison sampling.

• Perform destructive integrity testing on IV bags and maintain batch records/data sheets/controlled notebooks.• Distribute labeling materials and manage material transactions.• Perform rework inspections per material review board protocols and ANZI/ASQ Z1.4 charts.• Inspect production lines and clean rooms for line clearance.• Issue separations of material.• Review engineering work orders.

Shipping and Receiving Clerk• Physically/electronically receive, label, stock, and audit inventory. • Prepare assembly and subassembly kits for manufacturing per Bill of Materials. • Prepare shipping documentation and packaging for domestic and international export of equipment and spare parts. Manufacturing Associate• Perform visual, functional, and dimensional analysis on incoming raw materials against component specifications. File paperwork to disposition approved, rejected, or on-hold raw materials. • Assist in the manufacture of Low-Pressure RF Plasma Chemical Vapor Deposition Systems. Completed construction of various assemblies and subassemblies per specification drawings.