Fernando Gonzalez, Jr. Email & Phone Number

Los Angeles, Ca, Us

Santa Monica, California, Us

• Providing career development, coaching, and mentorship to a diverse team of 13-24 Cell Therapy Specialists, effectively addressing varying experience levels and enhancing team performance• Delivering on-floor support by troubleshooting, allocating resources, resolving conflicts, and conducting daily reviews of MFG production records and associated documents, enhancing operational efficiency and maintaining consistent production quality

Santa Monica, California, Us

• Tasked with organizing meetings, presentations, meeting facilitation, and data analysis for site's shipping document availability improvement project that involved assessing process mapping, cycle time tracking, and capacity calculation. This led to reduction of late documents from 49% to 16% and increased labor utilization by 18%• Initiated front line deviations and laboratory investigation reports, facilitated meetings with cross-functional groups to strategize immediate corrections, investigate root causes, and generate appropriate CAPAs, effectively managing risks to product quality, process, and systems• Qualified On-The-Job Trainer, Change Control Owner, and GVault QDMS Owner/Author/Reviewer/Approver

Santa Monica, California, Us

Clinical & Commercial Manufacturing of Autologous CAR-T therapies• Collaborated with Operational Excellence (OE) department to successfully lead renovation of MFG site's Tier 1/Tier 2 huddle boards. During the COVID-19 pandemic, this communication tool was converted into a transparent and effective virtual platform, ensuring safety measure compliance• Designed a Statistical Process Control (SPC) chart to track/trend MFG human errors, enabling the proposal and execution of impactful mitigation strategies that increased the Right First Time (RFT) rate by 6%• Oversaw and contributed towards the completion of the Waste Reduction initiative resulting in the identification and elimination of $1.5 million of process consumable waste• Conducted interviews, assisted with the selection of recruits, and participated in the onboarding of new hires to streamline the recruitment process• Co-launched the MFG site’s first, CTS led, RFT initiative and OE forum under the mentorship of a Certified Six Sigma Black Belt (CSSBB) consultant• Member of the Global OE Community of Practice team• Environmental Health & Safety (EHS) representative• Activities and Societies: GILEADOS; Gilead/Kite Cycling Club

Thousand Oaks, Ca, Us

Clinical Drug Product Fill & Finish Operations• Participated in Annual Bulk Hold Studies, Smoke Studies, Semi-Annual Aseptic Media Fills, and Engineering Runs that successfully met validation requirements• Troubleshoot and identified potential solutions for mechanical errors, safety issues, and operating inefficiencies within the production processes to improve overall efficiency• Executed equipment inspections and generated work orders for emergency repairs, corrective actions, or preventative maintenance to minimize downtime• Partnered with multiple cross-functional stakeholders to support New Product Introduction (NPI) and Technology Transfer, ensuring seamless coordination and implementation• Activities and Societies: Amgen Cycling Club

Riverside, Ca, Us

Evolutionary trade-off between genome level defense and limiting the acquisition of beneficial genomic material from exogenous sourcesFaculty Mentor: Dr. Derek O'Meara, Ph.D.

Riverside, Ca, Us

Studied various species of Phytophthora, a genus of Oomycetes responsible for Late Blight diseaseFaculty Mentor: Dr. Michael Coffey, Ph.D.

Bachelor Of Science (Bs), Cell, Molecular And Developmental Biology

Certification, Project Management

Biology/Biological Sciences, General

Microbiology, General