Hector Nuño

• Lead a group of engineers and scientists to execute projects and downstream activities against aggressive timelines. • Planning, preparing, and managing of day-to-day activities associated with downstream production. • Partner with QA, QC, RA, AD and PM to strategically bring programs forward. • Provide technical and project leadership in equipment commissioning, scale-up, data analysis, process operations and troubleshooting. • Provide guidance and training to team members.

• Provide technical process leadership to manufacturing to support Ph I through Ph III cGMP manufacturing. • Lead tech transfer efforts for internal and external manufacturing and support activities through process validation. • Support manufacturing investigations as required with batch record review, data analysis of results, experimental investigation planning and writing/review of technical reports. Manage investigations and address deviations and implement change controls. • Manage technology transfer from Development to internal and external manufacturing sites ensuring effective information flow, timeline execution, issue resolution, training, and documentation in accordance with governing tech transfer quality system requirements while leveraging robust risk management practices. • Primary point of contact for a CMO and person-in-plan (PiP) for critical manufacturing activities. • Work with Manufacturing staff for the preparation and review of necessary technical documentation (SOP’s, BPR’s, specifications, etc.).

o Lead a Pilot Scale Downstream team to execute the isolation and purification of AAV vector from clarified harvest to DP fill. Involved in scheduling and prepared team meeting agendas and meeting minutes. o Design and oversee a large-scale downstream process for the at scale commercial manufacturing process. o Author of technical documentation including master batch records and transfer protocols. o SME for TFF (UF/DF) and viral retention filtration; oversee the purification process using AKTA equipment. o Track consumables and raw material inventory records and prepare requisitions as necessary. o Stablished a platform to collect and analyze process trends to perform process improvements based on process responses and risk analysis with the intend to lower CoGs and increase process robustness. o Collaborate with other functional groups such as QA, QC and PS to develop buffer outsourcing capabilities.

-Technical lead for technology transfer, scale up and engineering activities for Veltassa drug substance. -Oversee all aspects of manufacturing activities including QA, RA, QC and raw material sourcing to successfully delivered CMO manufacturing timelines. -Travel overseas to act as man-in-plant at CMOs

-Guided a multidisciplinary group for the validation of the commercial process as part of the continual process improvement program. -Coordinated different groups to review, edit, track and approve change controls and deviation records. -Worked together with cross functional teams such as Quality Assurance, Regulatory Affairs, Quality Control, Supply Chain and Drug Product to ensure drug substance supply and supported activities to lower cost of goods.

-Collaborated with different teams to validate the drug substance intermediate commercial process (>2000 kg scale) and the drug substance commercial process (>3000 kg scale). -Author of regulatory sections in the Marketing Authorization Application (MAA) of Veltassa in the EU (Approved May 2017). -Technical lead for the development of a continuous processes to increase process efficiency. Utilized process analytical technology (PAT) to monitor different DSI attributes during the manufacturing process. -Supervise interns during our summer program.

-Supported the Veltassa launch by collaborating cross-functionally to ensure timely availability of drug substance supply. -Author of regulatory sections in the New Drug Application (NDA) of Veltassa in the USA (Approved in 2015).

- Executed lab experiments in support of the quality by design (QbD) programs to map out the proven acceptable ranges (PAR) and normal operating ranges (NOR) for the Veltassa drug substance commercial manufacturing process. -Led process development activities to support product supply for phase II and III clinical studies. -Collaborated with the analytical group and QC groups to develop impurity control strategies.

Professional Experience in Chemical Engineering; Experience Working with Drug Delivery Technology; Laboratory Experience Organic/ Inorganic Techniques (Including Colloidal Systems); Chemical Synthesis of Nanoparticles (organosilicate based particles); Experience in Aseptic Lab Techniques, PCR Thermocyclers, Autoclave, Electrophoresis, Handling Chemicals, Molecular Biology and Laboratory Equipment; Clean Room Knowledge; Extensively Trained in SEM and Knowledge in Analyzing TEM and AFM Data; Interacted Heavily with SPR, UV-Ozone, UV-Spectroscopy, IR Spectroscopy, Fluorescence Spectroscopy, Spin Coating, Metal Vapor Deposition, Contact Angle Measurements, Ellipsometry; Research and Development (R&D), Scale up; Experience Creating Fluidic Technology for Surface Plasmon Resonance Biosensors; Managing Laboratory Activities; Training Experience of Undergraduate Students; Experience Working Under a Regulated Enviroment; Excellent Presentation Skills, Research Paper Writing; Strong Leadership Skills and Abilities to Build Collaborative Teams; Strong Analytical and Organizational Skills; Simulation Programs (Sim-Sci, Super Pro), Data Acquisition and Data Analysis (Polymath, Origen); Experience with Microsoft Word, Excel and PowerPoint; Bilingual (Spanish/English)

Templated Core-Shell Silica Nanoparticles Key Contributor for the creation of a new class of complex core-shell silica nanoparticles Generated dye-occluded particles, and developed methods for silica encapsulation Devised and performed methods for size control to release or retain pharmaceuticals/dyes that can be beneficial for therapeutic areas Chemically modified the surface to generate resuspendable biocompatible particles (Surface tags/markers, PEGylation chemistry) Characterized particles with Fluorescence microscopy, SEM, TEM, AFM, DLS, UV-vis, IR, NMR, Dialysis, Solvent Solubility Surface Plasmon Resonance Biosensor Constructed organosilicate SPR-based biosensor for ex-vivo bio-applications Created thin films using Chemical Vapor Deposition (CVD) Nanostructured thin films with random or ordered porosity (Block-copolymer chemistry) Formulated methods to generate an antifouling surface using PEG polymers Tested the antifouling properties with bovine serum albumin (BSA) Characterized the biosensors with SEM, TEM, AFM, SPR, Ellipsometry, Contact Angle Measurements, UV-Ozonolysis Delivered weekly results to the management team via Power Point presentations

Achieved the mutation Gln317Ala using site directed mutagenesis in the ligand binding domain of the nuclear Vitamin D Receptor Gained knowledge in primer design, PCR, restriction digest, ligation, cloning transformation, plasmid isolation and purification Learned sterile techniques to isolate/transfer microorganisms to maintain cell cultures Conducted enzymatic reaction to isolate genes characterized by gel-electrophoresis Use radioactive isotopes to perform DNA-sequencing using acrylamide gels.