Paul Macias Email and Phone Number

• Perform all tasks associated with manufacture of clinical product following batch records and SOPs• Work as part of a small team to execute GMP runs in close collaboration with Process Development, Facilities, and Quality departments• Assist in the development of standard operating procedures (SOPs), master batch records (MBRs), deviations and change controls• Ensure right-the-first time performance of all process steps specific to the phase or state of operation, as well as drive the safety-first culture at ImmPACT-Bio• Assist with authoring new or revise existing SOPs, MBRs and other process documents• Successfully troubleshoot processing and equipment issues• Daily, real-time review of in-process cGMP documentation for completeness and accuracy• Assist with change control and investigations required to manage deviations • Train personnel on applicable procedures and equipment

• Work as part of a team to support production in an aseptic Grade A environment (AOQs, engineering runs, Media Simulations) as BSC operator, verifier and runner) This includes executing GMP production alongside quality and process development teams.• Create batch records, WINs, SOPs, FORMS, for the new processes and equipment including IOQs and risk assessment reviews• Participated walkthroughs and safety topics

- Completes documentation required by process transfer protocols, validation protocols, SOP’s and Batch Records. - Works as part of a team to execute GMP production alongside quality and process development teams. - Aseptic/ sterile techniques and prior experience working in a cGMP environment.- Assists in the development of manufacturing batch records, identify and investigate deviations and implement change controls.- Successfully troubleshoots processing and equipment issues.- Reports issues accurately and promptly. - Cleans manufacturing space. - Performs kitting operations in adherence to batch records and SOPs. - Assists in the day to day manufacturing operations, and identifies improvement opportunities. • Reviews completed batch records. - Assists in the establishment of systems as they pertain to the new manufacturing facility.

- Lyophilization startup, Filling gown qualified - Formulation and sterile filtration 5-products (Advate, Hemofile, Recombinate, Rixibus, and VONVENDI)- Passaging/Scale up in inoculation room Class 5- Aseptic technique for in process bioburden samples- Main contact for other departments on the floor, coordinate scheduling equipment for preventive maintenance and calibrations- Responsible for area readiness for walkthroughs- Participation on GMP and EHS audits- Daily and weekly pass downs including face-to-face shift hand-over meetings- Weighing, formulation, filtration of product, buffer, and media- BDS and vial thawing, pooling, inoculations- Coordinate training of employees- Review a variety of reports, records, and logs for completion and GDP- Pi trending, data collection - SIPs, CIPS, autoclaving, setup of equipment

- Supervise the day-to-day production, scheduling, staffing, material management, compliance, training, and auditing activities for area of responsibility. - Developed , trained, and managed performance of 10-direct reports- Supported and ensure execution of all manufacturing processes with strict compliance to cGMPs and EHS regulations- Preformed or supported technical reviews, investigation and process improvement projects; i.e. I was assigned two internal audit responses and completed them both on time.- Subject Matter Expert: provided input into integration and validation of new equipment and process; i.e. CIP 100/200- Subject Matter Expert: Resolve technical, material, and cGMP issues (Cell Culture SME)- Reviewed, approved, and managed documentation for batch and system records and production- Interfaced with other departments to resolve issues related to equipment, process and compliance including facility support department and external vendors. i.e. Heat Exchanger project, replaced open steam setup to warmup media component with a heat exchanger, also obtained new harvest carts- Lead/participated in technical reviews, investigation and process improvement projects in order to meet objectives. i.e. DMAIC for seed bioreactor hi pH, and low/high yield investigations - Initiate document change proposals, prepare/review protocols to justify process changes, assist with training and auditing as appropriate. i.e. created URS for formulation tanks - Leader for implementation of new equipment, system procedures; i.e. Optical dO probes, sample bags, etc. - Participated in internal and external audits as SME for the Cell Culture department

• Supervised the day to day production, scheduling, staffing, material management, compliance, training, and auditing activities for area of responsibility. • Developed and managed performance of 10 direct reports. • Supported and ensure execution of all manufacturing processes with strict compliance to cGMPs and EHS regulations. • Performed or supported technical reviews, investigation and process improvement projects. • Provided input into integration and validation of new equipment and process. • Resolved technical, material, and cGMP issues. • Reviewed, approved, and managed documentation for batch and system records for production. • Interfaced with other departments to help resolve issues related to equipment, process and compliance including facility support departments and external vendors. • Lead/participated in technical reviews, investigation and process improvement projects in order to meet objectives • Assess impact of new regulatory guidelines on current practice, initiate document change proposals, prepare/review protocols to justify process changes, assist with training and auditing as appropriate. • Owner for implementation of new equipment, system and/or procedures. • Participated in Internal or external audits as SME for department.

- Assist supervisor in organizing team members, meetings and passdowns- Execute and direct manufacturing operations, daily schedule assignments, rotations- Main contact for other departments on the floor, scheduling calibrations and PMs- Communicated any discrepancies or issues to management- Resolve concerns and disputes associated with employees and other issues- Present approved awareness/supplemental training to employees on the equipment and SOP updates- Trained new employees, scheduled employee’s training- Led troubleshooting and investigation of equipment issues- Ensure equipment and supplies prepared per schedule - Trained 4 waves of Singapore employees for 1 year

• Review and assess logs and information per GDP (Good Documentation Practices)• Perform and coordinate as working inoculum lead operator• Initiate and write CRs• Perform special projects; i.e. purge study

• Assist other departments; i/e/ validation SIPs• Training and verifying employees for GMP/GDP• GMP representative for cell culture

• Perform SIP/CIP assembly of equipment and systems, inoculations• Cell enumeration and calculations• Sampling using aseptic techniques, passaging