Ignacio Núñez Email & Phone Number

Houston, Tx, Us

Houston, Tx, Us

Expertise and Capabilities: • Manufacturing Excellence: end-to-end operations scape up, CMC, cGMP readiness, manufacturing facility design and construction. • Organization Assessment and Design: optimization of organization design and operating model to improve performance. • Executive Advisory: strategy execution and organizational change. Confidential sounding board on leadership and culture challenges.• Leadership Team Efficiency: simplify leadership teams to clarify roles, prioritize initiatives, make difficult decisions, and build alignment and accountability for execution (governance). We are change managers. • Cell and Gene Therapy Business Model: biotech corporate structure, transformation from lab to biotech, investors relation. We assess market opportunities and/or outline development strategies. Assist with due diligence projects and partnerships. We are senior advisors to VC and PE.Recent Assignments:- Acting CEO AAV CDMO- Acting Head Technical Operations Cell Therapy Company- General Manager CellReady (Houston)

Houston, Tx, Us

Responsible for:• Leading and establishing the operations organization, including Process Unit,Supply Chain, QA, QC, Engineering/Facilities, EHS and IT.• Leading the CMC (Module 3) remediation program for IND submission of two celltherapies for solid tumors.• Implementing new functional organization, IT framework, corporate governance,quality system, manufacturing planning, corporate branding among others.

Philadelphia, Pennsylvania, Us

Responsible for:• Establishing the manufacturing organization in research and preclinical and the build-out of a CDMO to support early/late phase clinical trials and commercialization of gene therapy products. • Establishing the strategies for current and future sites for the manufacturing team to deliver high-quality viral vectors (AAV) for gene therapy research and clinical trials. • Implementing new policies and systems to ensure high quality GMP manufacturing.

Basel, Baselstadt, Ch

Tapped by executive leadership to lead the transformation of a manufacturing organization to manufacture and market Kymriah, the first FDA-approved CAR-T cell therapy for the treatment of acute lymphoblastic leukemia and diffuse large B-cell lymphoma. • Developed multiyear manufacturing roadmap and infrastructure to include production scale up, technology transfer, quality, talent management, performance management, governance, global product development and supply.• Applied LEAN methodologies to redesign the manufacturing organization that increased patient throughput, doubled capacity, and added $100 million in production capacity without additional FDA approval.

New Brunswick, Nj, Us

(J&J Vision was formerly Abbott AMO)• Recruited and developed a 25-member leadership team with a focus on building an organized, integrated, and disciplined global work culture.• Created and deployed a talent management program to encourage scientific thinking, idea generation, succession planning, coaching and performance management. Instituted Continuous Improvement Awards Program. • Delivered $50+ million in hard cost savings within one year.

Amsterdam, Noord-Holland, Nl

• Reassigned to New York to build and direct a multidisciplinary team of 30 in the total transformation of a $3+ billion multisite manufacturing organization employing a staff of 5,000+. • Collaborated with regional leaders to develop and execute an enterprise-wide continuous improvement program and standardized metrics and dashboards to improve business performance and mitigate risk.• Identified and resolved issues regarding FDA quality and compliance, service delivery, operating management, market to order and supply chain.• Facilitated training of 600+ in root cause analysis (RCA), process mapping, DMAIC and change management. • Generated $40+ million in cost savings across supply chain, manufacturing, and product development.

Amsterdam, Noord-Holland, Nl

• Directed PMO leadership team in delivering $25+ million in annual savings.• Established a Center of Excellence and served as Chief of Staff to Chief Strategy & Innovation Officer. • Guided global implementation of Design for Excellence (DfX) that encompassed Design for Manufacturing (DfM), Design for Cost/Design for Procurement (DfC/DfP), Quality by Design (QbD) and Design for Six Sigma (DFSS).

Dublin 2, Ie

Recruited as a LEAN SME to direct a team of ten consultants on high-profile projects for British Telecom, Airbus and Siemens Gamesa. • Engaged in strategy development, value stream mapping, construction, and procurement improvements.

Boston, Ma, Us

Selected from a competitive group of graduate students for inclusion in fast-track, two-year operations management leadership program gaining extensive experience in supply chain management, distribution, and manufacturing operations.• Masterminded sophisticated solution to predict reactor malfunctions in chemical plants that was adopted as standard operations in Spain and The Netherlands.• Challenged as Black Belt Initiation Leader to deliver an end-to-end value chain transformation across four manufacturing facilities in The Netherlands, France, Italy, and the United Kingdom.• Performed capacity, throughput, and root cause analyses, identified capacity improvements and best practices, and led training that generated 30% average additional capacity valued at $10 million annually with a 20% improvement in service delivery.• Promoted to Global Master Black Belt after the SABIC/GE Plastics merger to lead the training of 400+ black belts across the globe for SABIC.

Master Of Science (Msc), Chemical Engineering

Education record

Post Grad Studies, Chemical Engineering

Doctor Of Philosophy - Phd, Biomedicine

Education record

Education record