• Lead Engineering runs at a Hybrid-type CMO (CMO MFG operators and Angiocrine MFG operators) for scale-up operations using an alternate Single-Use Bioreactor (SUBs) system in prep for commercialization activities, comparability studies.• Helped improve the scale-up process at the Hybrid CMO which contributed to a 50% increase in drug product output.• Provided Lessons Learned training after each engineering run to staff to demonstrate operational processes that were completed successfully, and solutions for process steps that needed improvements.• Served as a Person in Plant (PiP) and managed CDMO operations in the cleanroom of phase 3 clinical drug product from cell thaw, bioreactor inoculation, bioreactor harvest, centrifugation, final product vial filling and drug product cryopreservation. • Provided leadership, guidance, training, and direction to staff in alignment with cGMP requirements at multiple CDMOs.• Collaborated with area managers to ensure accuracy and adherence to production schedules.• Proactively identified and assessed operational risks, communicated issues to senior management and cross-functional support teams.• Develop, implement, and update production SOPs, Batch Records and other documentation needed for GMP production while aligning with ALOCA+ principles.• Helped Process Development (PD) evaluate and execute multiple runs to improve the manufacturing process and prep for commercialization activities. • Evaluated and started implementation of new equipment for crimping seals (20 mm, 13 mm) for use in Final Finish of drug product in CZ Vials (5 mL, 2 mL) in prep for commercialization activities.• Helped evaluate other CDMOs in preparation for commercialization activities; initiated contact, coordinated introduction meetings, visited the CDMO sites, and participated in on-site walk-throughs of operations.

•Involved with leadership of manufacturing activities at the Carlsbad Viral Vector Manufacturing site.•Responsible for ensuring the successful GMP manufacture and release of products, promoting a culture of quality and compliance, and continuous improvement.•Responsible for leading the manufacturing staff working in the facility to meet corporate production goals, as well as influencing related, cross-functional groups to meet these objectives.•Ensure the facility and equipment is maintained in a cGMP compliant state and ready for use.•Ensure that the manufacturing facility operates according to cGMP regulations. •Maintain operations within contracted guidelines in order to successfully produce high quality bulk and finished products. •Build and maintain a staff that is both technically qualified and well trained in cGMP manufacturing, while providing a motivating environment and opportunities for their professional advancement in a safety conscious environment.•Define, implement, and optimize the manufacturing schedules. •Ensure consistent product quality through appropriate manufacturing programs and by working with other groups such as Quality Control and Quality Assurance.•Develop, implement, and update production SOPs, Batch Records and other documentation needed for GMP production projects.•Ensure that deviation reports are written accurately and appropriately as they occur. Track and implement corrective actions, CAPAs. •Evaluate employee efficiency and productivity.•Provide and work with Tech Transfer group for hands on training with Manufacturing Team on mammalian cell expansion platforms T-Flasks, CellSTACKs, HyperSTACKs, Erlenmeyer Flasks, Spinner Flasks, Single Use Bioreactors (SUBs) for Adherent iCELLis system & Suspension cell lines, downstream purification methods; Ultracentrifugation, Clarification, BPG Columns, RTU columns, AKTA ready single-use system, TFF systems (Ultrafiltration & Diafiltration), Final Filtration and Formulation.

• The primary entry point for taking on project responsibility at the Carlsbad site.• Manufactures cGMP grade Product, with a selection of Biomanufacturing Tech positions used in a supporting function.• Overall responsibility for the projects assigned.• Develops custom Master Batch Records, communication with internal and external clients and performs cGMP manufacturing operations.• Ensures the team is properly prepared and trained and demonstrates good documentation practices in accordance with cGMP standards.• Operates in a manner that promotes the safety and wellbeing for both employees performing the work, as well as the product being manufactured.• People Manager: lead and develop manufacturing techs achieve personal and company’s goals and objectives. • Provide and work with Tech Transfer group for hands on training with Manufacturing Team on mammalian cell expansion platforms T-Flasks, CellSTACKs, HyperSTACKs, Erlenmeyer Flasks, Spinner Flasks, Single Use Bioreactors (SUBs) for Adherent iCELLis system & Suspension cell lines, downstream purification methods; Ultracentrifugation, Clarification, BPG Columns, RTU columns, AKTA ready single-use system, TFF systems (Ultrafiltration & Diafiltration), Final Filtration and Formulation.

• Project Planning and execution of cell thaw, cell expansions, and downstream.• Support in completion of deviations, investigations, corrective and preventive actions.• Continued training support in GMP technical production.• Create and update SOPs, and Batch Records as needed.• Provide instruction and guidance to team members to prevent errors.• Lead the execution of projects.• Reinforce cGMP documentation guidelines.• Set a good example in observance of cGMP and Quality.• Demonstrate leadership by example and participation.• Review pre-recorded data for accuracy and completion.• Assist in the introduction of new manufacturing platforms into the GMP manufacturing facility.• Reinforce cGMP documentation guidelines.• Works off-shifts, weekends, and additional hours as required.• Performs very complex tasks with attention to detail.

• Responsible for performing cell culture, buffer, and Media preparation.• Responsible for membrane clarification, TFF (UFDF) concentration and buffer exchange, column purification.• Responsible for drafting Batch Production Records and Standard Operating Procedures.• Responsible for troubleshooting equipment and process failures.• Recognize common equipment failures and process anomalies.• Assist in Deviation Investigations, Corrective Action, Preventative Action, and Document Training.• Train MFG Staff in Cell Culture which includes; Cell Thawing, Cell Counting, Adherent and Suspension Cell Expansion using T-Flasks, CellSTACKs, HyperSTACKS, Erlenmeyer Flasks, and Spinner Flasks.• Train MFG Staff in Cleanroom Requirements which includes Cleanroom Conduct, Facility Flows for (Personnel, Materials, Equipment, Product and Biohazard Waste), Gowning for the Facility and Fill/Finish Suite, Aseptic Techniques in the BSC and Personnel/Settling Plate Monitoring• Train MFG Staff in Fill and Finish Procedures which includes; Aseptic Filtering, Filling/Stoppering Operator, Finishing Operator (Crimping using the Flexicon FlexSeal 10 Crimper), Support Operator, and Visual Inspection of Vials.• Train MFG Staff in Plate and Frame UF/DF Set-up and Operation.• Train MFG Staff in Component Preparation which includes; Prepare daily cleaning solutions, Tubing and Filter Assemblies, Wrapping of Materials to be Autoclaved, Autoclave Load Configurations, Operation of the Steris/Finn-Aqua GMP Autoclave, and Operation of the Sartorius Sartocheck Filter Integrity Tester.

• Responsible for biological and chemical evaluation of final products, intermediate products, raw materials and production facilities.• Analytical Assays; Adenovirus HPLC, Reverse-Phase purity HPLC, Bioburden, Filter Integrity, Osmolality, Total Organic Carbon (TOC), Viral Particle Quantification with UV/OD Spectrophotometer, Glucose/Glutamine YSI Biochemistry, Specific Gravity, CFU Quantification. • Raw Material Identification (ID) Assays via USP methods; Polysorbate ID, Hydrogen Peroxide ID, Acetate ID, Phosphate ID, Edetate Disodium (EDTA) ID, Chloride ID, Carbonate/Bicarbonate ID, Potassium ID, Sodium ID, Ethanol ID, Sodium Hypochlorite ID, Calcium ID, Total Protein Assay (TPA), pH, Conductivity, Nitrogen Gas ID, Carbon Dioxide ID, Fetal Bovine Serum electrophoresis ID, Benzonase electrophoresis ID• Process in-coming samples in a timely and quality manner. • Reports results appropriately and efficiently, performs biological and chemical assays.• Maintaining assay database and provide trends as required. • Maintain assay reagents and controls inventories. Ensure laboratory materials are requisitioned and ordered if required.• On-going cross-training with Cell Culture lab as a backup for ELISA assays, BSA and Benzonase, also for Polymerase Chain Reaction (PCR) assay. • Executing and helping to develop optimization, qualification for quantification of adenovirus particles using HPLC.

• Conducted environmental monitoring tasks.• Responsible for personnel monitoring and gown qualifications. • Performed dynamic and non-operational monitoring of the manufacturing facility. • Maintained equipment essential for environmental monitoring. • Supported Manufacturing operations via QC function.• Prepared and autoclaved necessary materials prior to environmental monitoring.