Alex Young
Senior Leader In End-to-End Biotechnology Operations
San Francisco Bay Area,
Summary
Experienced biotechnology manufacturing leader with 27 years of success in large pharmaceutical organizations and start-up environments. Skilled in leading cross-functional teams to foster innovation, ensure operational excellence, maintain quality assurance, and comply with regulatory standards. Proficient in strategic planning, optimizing processes, and managing resources to achieve production goals and drive business objectives. Comprehensive expertise throughout the entire product lifecycle, from initiating R&D programs and launching commercial products to establishing manufacturing sites, overseeing operations, and managing site closures.
Overview
27
27
years of professional experience
Work History
Lead, AAV Production Operations
Astellas Gene Therapies
06.2024 - 04.2025
- Directed the full lifecycle management of test articles for early R&D programs, achieving seamless progression through Candidate Nomination (CN).
- Led the Test Article Coordination and Scheduling Meetings, overseeing strategic planning and execution to ensure timely production and delivery. Directed the Test Article Lifecycle Management Teams, driving collaboration, efficiency, and compliance across all stages of development.
- Collaborated with cross-functional teams, including Process Science, R&D, Pilot Plant, Analytical Operations, and Study Managers, to ensure timely and efficient test article production.
- Developed manufacturing cost models and implemented a program chargeback process for Test Article production
- Developed Pilot Plant capacity and program budgeting tool, managed the Pilot Plant’s EM program, and provided Pilot Plant compliance and efficiency guidance for GLP readiness
Associate Director of Manufacturing
Astellas Gene Therapies (formerly Audentes Therapeutics)
04.2016 - 04.2024
- Member of the Site Leadership Team (SLT), providing strategic guidance and direction to site operations.
- Led a manufacturing team of 48 professionals, designing, implementing, and overseeing Drug Substance and Drug Product operations.
- Spearheaded the inception, launch, and eventual closure of a new manufacturing facility, including technology transfers and program transitions.
- Managed production schedules, integrated new programs, and led the preparation and execution of PPQ runs.
- Served as the manufacturing CMC representative, supporting product lines and contributing to regulatory submissions, including IND filings.
- Oversaw production costing and managed a $60 million departmental budget, implementing an ERP system, optimizing workflows, and driving continuous improvement initiatives.
- Ensured regulatory compliance, facilitated audits, and served as the primary liaison with regulatory authorities during inspections, while leading staff training and preparation efforts.
Senior Supervisor Fermentation
Grifols Diagnostics Solutions (formerly Novartis)
01.2013 - 03.2016
- Successfully revitalized department operations by enhancing compliance, quality standards, efficiency, and team morale, achieving a 40% reduction in human error discrepancies. Earned Green Belt in Operational Excellence in recognition of these accomplishments.
- Oversaw production of 14+ Yeast and E.coli hosted antigens, developing optimized production schedules aligned with customer demand, resource availability, and equipment utilization.
- Created process orders, issued batch records, and ensured production metrics attainment
- Served as area and equipment owner, leading FDA, ISO, and internal audits of the Fermentation area to ensure regulatory compliance.
Drug Substance Supervisor (Cell Culture and Purification)
Genentech
01.2006 - 01.2013
- Supervised large-scale CHO Cell Culture operations (20L–12K bioreactors) and final purification processes utilizing column chromatography and TFF methods.
- Spearheaded safety improvement initiatives by developing key safety metrics, representing the department at SIT Counsel, and implementing data driven safety enhancements.
- Led discrepancy resolution efforts through Trackwise, conducted Root Cause Analysis (RCA) as a qualified RCA Facilitator.
- Directed process optimization initiatives, including 5S audits, audit checklist development, and achieving Class A manufacturing certification.
- Served as SME for SAP and MES systems, establishing labeling standards to streamline operations across the Drug Substance Manufacturing site.
Drug Product Manufacturing Supervisor
Genentech
01.2004 - 01.2006
- Led commercial packaging operations, optimizing task coordination, resource allocation, and production scheduling to ensure seamless execution. Managed priorities to drive efficiency, maintain workflow continuity, and meet delivery timelines in a fast-paced manufacturing environment.
Production Supervisor
Becton Dickinson (BD) Clontech Laboratories
07.1998 - 01.2004
- Managed the production of multiple product lines, leveraging PCR, gel electrophoresis, and antibody purification techniques to ensure high-quality output and process efficiency. Oversaw workflow optimization, troubleshooting, and quality control measures to maintain compliance with industry standards and production goals.
Education
Bachelor of Science - Biological Sciences
University of California, Irvine
Irvine, CA 05.2001 - 06.1998
Skills
- Leadership and Strategic Management
- Operations Knowledge and Experience
- Comprehensive Expertise of Product Lifecycle
- Regulatory Expertise and Compliance
- Project Management Skills
- Cost management and Budgeting
Timeline
Lead, AAV Production Operations
Astellas Gene Therapies
06.2024 - 04.2025
Associate Director of Manufacturing
Astellas Gene Therapies (formerly Audentes Therapeutics)
04.2016 - 04.2024
Senior Supervisor Fermentation
Grifols Diagnostics Solutions (formerly Novartis)
01.2013 - 03.2016
Drug Substance Supervisor (Cell Culture and Purification)
Genentech
01.2006 - 01.2013
Drug Product Manufacturing Supervisor
Genentech
01.2004 - 01.2006
Bachelor of Science - Biological Sciences
University of California, Irvine
05.2001 - 06.1998
Production Supervisor
Becton Dickinson (BD) Clontech Laboratories
07.1998 - 01.2004
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