Austin Walter Email and Phone Number

Manage a diverse portfolio of emerging biologics (Cell and Gene Therapy and ADC investigational products) responsible for clinical production of API/DS/DP at external contract manufacturing organizations. • Collaborate with Legal, Procurement, Quality and External CMO business partners to create Master Service Agreements, Work Order Statements and Quality Agreements• Manage overall relationship with strategic partner CMO to ensure reduced cost and schedule as single point of contact between Janssen and CMO for multiple programs to ensure flexibility• Prepare business plan forecasts and monitor actual spend v.s. budget for programs totaling > $25MM• Collaborate with cross functional teams internal and external to ensure successful tech transfer and production of clinical supplies• Re-evaluated and standardized the process for CMO facility/GMP risk assessment to ensure success prior to manufacturing to promote Right First Time

Global Engineering Solutions Vaccine Technology Facilitated and led project design and execution from Concept (FEL 2) through C&Q complete on high profile projects including Elkton, VA Gardisel-9 Facility, West Point, PA LVV Lyo Facility and Facility Renovation for BFS and Durham, NC J&J COVID-19 Collaboration • Responsible for key design decisions on technical equipment including utilities, Autoclave/Parts Washer Combo, Isolators, Blow Fill Seal (BFS) Equipment, Homogenizer and Single Use Bioreactors• Contributed to design phase HAZOPs, GEMBA Walks and Quality Risk Assessments; identifying design and operational improvements to increase safety, operational efficiency and design redundancy. • Evaluated designs to reduce capital cost and operational cost such as limiting CIP/SIP required equipment, material transfer technologies and design for purpose areas using lean principles• Coordinated with operations, quality, environmental and safety, engineering firm and vendors to achieve a similar goal of an effective facility to manufacture lifesaving Products • Led equipment C&Q testing between Operations, Technical Operations and Automation to ensure proper operation and qualification of the process• Supported PPQ Batches (Drug Substance) through analyzing data, production schedule and trouble shooting

Special Assignment to aid in the design, technical transfer and operational decisions of a drug product utilizing blow, fill, seal technology in a modular manufacturing facility. • Developed Standard Operating Procedure Management and executing SOP transfer and creation• Created process fit and material balance to predict inventory/processing time, document critical processing operations and aid in MES/PAS-X creation• Evaluating critical process and design requirements to reduce project expenses such as process simulation testing plan to avoid $0.5 M capital expense.Ensured product quality, safety and process stability for the manufacturing of large molecule non-sterile API.• Implemented continuous improvement of procedural and physical controls resulting in improved efficiency and quality compliance• Investigated safety and quality events to find and eliminate the root cause to ensure a safe work environment and on schedule product delivery• Coordinated bulk solvent tank cleaning and restoration with quality, environment, operations and safety departments to reduce processing down time.• Co-Instructed Merck & Co. Certified Root Cause Analysis Training • Investigated the utilization of Data Lake to analysis process control parameters reducing manual data mining

Responsible for ensuring an efficient environment for manufacturing sterile injectable drug products. • Designed and built training equipment to produce a reduction in operator defects/error• Processed material and equipment needed for the manufacturing batches • Conducted Performance Qualification (PQ) studies on manufacturing machines change parts• Wrote and revised User Requirement Specifications(URS) and Design Qualifications(DQ) for process equipment to ensure process specifications were meet• Decommissioned unused equipment to reduce storage needs with collaboration of project manager and warehouse personnel.

Responsible for operating, sanitizing and maintaining process equipment aiding in the achievement of a cGMP environment for the production of nasal spray drug products.• Supervised assembly manufacturing area• Assisted with training of team members on Work Instructions and equipment• Resolved problems with the labeling equipment to reduce down time• Identified areas for improvements to reduce unnecessary motion in packaging process• Wrote and revised SOPs

Instructor for a small class of 8-10 students that explains and leads discussion about General Chemistry II.• Created an agenda for the class meetings and managed all logistics of course• Fluently presented and explained concepts of chemistry