Josiah H. Reyes Email and Phone Number

•Integrated a comprehensive Quality Management System (QMS) with cGMP production activities.•Create, evaluate, and optimize quality assurance protocols, SOPs, batch records, and training documents to ensure cGMP compliance.•Enhanced supplier quality management through audits and inspections.•Improved product quality and production efficiency through continuous process optimization.•Managed documentation, change control, and non-conformance reports to maintain high quality standards.•Facilitated cross-functional collaboration to streamline operations and maintain high product quality.•Contributed to the advancement of microbiome sciences and patient-centric medical innovations through hands-on manufacturing and quality assurance activities.

• Spearheading the development of scale-up parameters, optimizing production efficiency.• Orchestrating hands-on operations for LBPs, ensuring precision in Fermentation, Purification, Lyophilization, Encapsulation, and deep cold preservation.• Contributing to the collection and development of research and development data, showcasing team’s analytical prowess.• Maintaining lab equipment, enhancing reliability through routine maintenance.• Developing in-process QC testing for drug substance and products.•Upholding top-tier workplace safety standards, fostering a GLP compliant environment.

• Supported growth within a fully cGMP compliant setting of mammalian cell line necessary for the gene therapy (Zolgensma®).• Growth Promotion and Isolation of molds and bacteria required for investigation and/or qualification.• Supported Filling Operations and filler qualification operations.• Certified to gown into ISO A, B, C, and D environments.• Assisted with validation testing.• Collaborated across multiple departments to approve batch release and documentation reviewof cGxP documents (QCSM and MFG).• Performed microbiological testing (bioburden, bacterial endotoxin, cell passaging, andenvironmental monitoring) to support manufacturing and product batch release.• Provided leadership and technical guidance to less experienced staff.

Performed Microbiological testing in support of manufacturing at the Novartis Gene Therapies GMP Manufacturing facility. Routine product and raw material testing, environmental monitoring of the manufacturing cleanrooms and processes, method and instrument qualifications, supported investigative testing, team drafting and revising SOPs & reports.

Conducting daily analytics for both OTC drugs & cosmetics, SOPs, troubleshooting internal problems, and managing product quality.▪ Working on a 5-member team successfully operating 3 functional labs (raw material, microbiology, & FI) testing all products prior to entry into the consumer market.▪ Testing including XRD, GC, LC/MS, FTIR, UV-Vis, LOD, titrations, RI, specific gravity, KF, Viscosity, micro testing, and organoleptic testing.

Leveraged exemplary analytical abilities to extract and analyze extensive data to construct the foundation of the world’s largest cancer genomics database. Consistently retained optimal quality standards by pinpointing and rectifying errors in abstracted data.Produced numerous batches of clinical data contributing to the treatment & research for patients with several cancer types. Successfully trained in and coded for 2 cancer types (colon and rectal cancer).

Discussion Panel (Topic: Schizophrenia)Coordinated Simulated encounters with an individual suffering from schizophrenia, in order to train police officers to properly identify and handle severe cases of the disease.• Worked to provide crisis intervention certification for over 50 officers each session• Recommended by the Director of NAMI Milwaukee and selected to assist with training• Over 98% certification rate to properly deescalate and engage with individuals suffering from mental illness

Coordinating daily activities, managing daily activities & events, communicating with parents and children, resolving conflict, and providing CPR/AED & first aid.• Managed 30+ children & 2 counselors to achieve weekly goals discussed in weekly meetings.• Educated children daily while providing daily schedules and coordinating events for other counselors to follow.• Contributed to the safety and organization of the camp as well as communicating any concerns or events to parents or government officials in charge of the park district.